Trial Outcomes & Findings for The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients. (NCT NCT02336607)
NCT ID: NCT02336607
Last Updated: 2015-03-23
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
529 participants
Primary outcome timeframe
14 weeks
Results posted on
2015-03-23
Participant Flow
Patients enrolled in 10 centers in the People's Republic of China. First patient screened on 26th Dec. 2005, last patient completed last visit on 17th Aug. 2006. A total of 529 patients attended the screening visit. ITT population (481),PP population (390), Safety population (522).
After enrollment, 7 did not take the test medicine, 522 were given felodipine 5 mg once daily. Of these, 38 patients did not complete the 2-week felodipine monotherapy period.
Participant milestones
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
92
|
267
|
|
Overall Study
Patients Included in ITT Population
|
84
|
84
|
91
|
222
|
|
Overall Study
Patients Included in PP Population
|
78
|
75
|
75
|
162
|
|
Overall Study
Patients Included in Safety Population
|
85
|
85
|
92
|
260
|
|
Overall Study
COMPLETED
|
81
|
75
|
86
|
180
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
6
|
87
|
Reasons for withdrawal
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
4
|
3
|
15
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
21
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
3
|
|
Overall Study
Adverse Event
|
0
|
2
|
2
|
26
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
20
|
Baseline Characteristics
The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients.
Baseline characteristics by cohort
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=84 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=84 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=91 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=222 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
Total
n=481 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.4 Years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
55.2 Years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
55.6 Years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
55 Years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
54.9 Years
STANDARD_DEVIATION 10.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
110 Participants
n=7 Participants
|
215 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
112 Participants
n=7 Participants
|
266 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=78 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=75 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=75 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=181 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
|
74.1 Percentage
Interval 64.5 to 83.6
|
80.5 Percentage
Interval 71.7 to 89.4
|
80.2 Percentage
Interval 71.8 to 88.6
|
NA Percentage
Not include in the analysis of primary end point
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=83 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=84 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=91 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=193 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
|
45.8 Percentage
Interval 35.1 to 56.5
|
59.5 Percentage
Interval 49.0 to 70.0
|
46.2 Percentage
Interval 35.9 to 56.4
|
NA Percentage
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=84 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=81 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=89 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=181 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
|
78.6 Percentage
Interval 69.8 to 87.3
|
79 Percentage
Interval 70.1 to 87.9
|
78.7 Percentage
Interval 70.1 to 87.2
|
NA Percentage
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=83 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=84 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=91 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=193 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of systolic blood pressure
|
-10.3 mmHg
Standard Deviation 2.0
|
-13.4 mmHg
Standard Deviation 1.8
|
-9.8 mmHg
Standard Deviation 1.4
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of diastolic blood pressure
|
-7.3 mmHg
Standard Deviation 1.5
|
-9.9 mmHg
Standard Deviation 1.4
|
-6.0 mmHg
Standard Deviation 1.0
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=84 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=81 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=89 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=181 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of systolic blood pressure
|
-17.8 mmHg
Standard Deviation 2.2
|
-18.0 mmHg
Standard Deviation 1.9
|
-16.4 mmHg
Standard Deviation 1.5
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of diastolic blood pressure
|
-11.3 mmHg
Standard Deviation 1.3
|
-12.1 mmHg
Standard Deviation 1.2
|
-10.7 mmHg
Standard Deviation 0.9
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=81 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=77 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=86 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=181 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of systolic blood pressure
|
-16.6 mmHg
Standard Deviation 2.1
|
-18.0 mmHg
Standard Deviation 1.9
|
-16.8 mmHg
Standard Deviation 1.4
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of diastolic blood pressure
|
-10.7 mmHg
Standard Deviation 1.5
|
-12.8 mmHg
Standard Deviation 1.3
|
-10.6 mmHg
Standard Deviation 1.0
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=38 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=50 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=42 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=190 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of systolic blood pressure
|
-16.1 mmHg
Standard Deviation 2.2
|
-17.1 mmHg
Standard Deviation 1.6
|
-16.4 mmHg
Standard Deviation 1.4
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of diastolic blood pressure
|
-12.3 mmHg
Standard Deviation 1.6
|
-10.9 mmHg
Standard Deviation 1.2
|
-8.2 mmHg
Standard Deviation 1.0
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=66 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=64 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=70 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=180 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of systolic blood pressure
|
-19.4 mmHg
Standard Deviation 1.6
|
-19.7 mmHg
Standard Deviation 1.4
|
-18.5 mmHg
Standard Deviation 1.1
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of diastolic blood pressure
|
-13.4 mmHg
Standard Deviation 1.1
|
-13.1 mmHg
Standard Deviation 0.9
|
-11.5 mmHg
Standard Deviation 0.7
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=60 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=62 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=69 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=176 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of systolic blood pressure
|
-18.4 mmHg
Standard Deviation 1.7
|
-20.3 mmHg
Standard Deviation 1.5
|
-18.2 mmHg
Standard Deviation 1.2
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Change of diastolic blood pressure
|
-13.0 mmHg
Standard Deviation 1.2
|
-13.6 mmHg
Standard Deviation 1.1
|
-12.2 mmHg
Standard Deviation 0.8
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=33 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=32 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=35 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=181 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
|
-0.12 m/s
Standard Deviation 0.27
|
-0.44 m/s
Standard Deviation 0.38
|
-0.06 m/s
Standard Deviation 0.27
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of The change of pulse wave velocity at baseline and from at least one visit after randomization.
The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=33 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=32 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=35 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=181 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
week 14
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
-0.86 m/s
Standard Deviation 1.93
|
|
The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
week 2
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
NA m/s
Standard Deviation NA
Not include in the analysis of this end point
|
-0.58 m/s
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.
The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.
Outcome measures
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=84 Participants
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=84 Participants
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=91 Participants
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=208 Participants
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone
Change of diastolic blood pressure
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
-15.1 mmHg
Standard Deviation 8.2
|
|
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone
Change of systolic blood pressure
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
NA mmHg
Standard Deviation NA
Not include in the analysis of this end point
|
-22.8 mmHg
Standard Deviation 11.2
|
Adverse Events
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Felodipine Tablet (Plendil)+Hydrochlorothiazide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Felodipine Tablet (Plendil)
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=85 participants at risk
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=85 participants at risk
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=92 participants at risk
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=260 participants at risk
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal system damage
|
0.00%
0/85
|
0.00%
0/85
|
0.00%
0/92
|
0.38%
1/260
|
|
Nervous system disorders
Nervous system damage
|
0.00%
0/85
|
0.00%
0/85
|
0.00%
0/92
|
0.38%
1/260
|
Other adverse events
| Measure |
Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)
n=85 participants at risk
Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
|
Felodipine Tablets (Plendil)+Lisinopril (Zestril)
n=85 participants at risk
Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
|
Felodipine Tablet (Plendil)+Hydrochlorothiazide
n=92 participants at risk
Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
|
Felodipine Tablet (Plendil)
n=260 participants at risk
Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.7%
4/85
|
5.9%
5/85
|
4.3%
4/92
|
12.7%
33/260
|
|
Vascular disorders
Flushing
|
8.2%
7/85
|
3.5%
3/85
|
5.4%
5/92
|
5.0%
13/260
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place