Trial Outcomes & Findings for Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension (NCT NCT00699192)
NCT ID: NCT00699192
Last Updated: 2011-06-06
Results Overview
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
COMPLETED
PHASE3
965 participants
Baseline to end of study (Week 8)
2011-06-06
Participant Flow
965 patients were enrolled in the study. Of these, 819 met the criteria for entry into the double-blind phase of the study where efficacy and safety were evaluated.
Participant milestones
| Measure |
Amlodipine/Valsartan 5/80 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
275
|
272
|
272
|
|
Overall Study
COMPLETED
|
259
|
260
|
261
|
|
Overall Study
NOT COMPLETED
|
16
|
12
|
11
|
Reasons for withdrawal
| Measure |
Amlodipine/Valsartan 5/80 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Overall Study
Missing
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
9
|
4
|
3
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
4
|
|
Overall Study
Administrative problems
|
1
|
3
|
1
|
|
Overall Study
Protocol Violation
|
2
|
2
|
0
|
Baseline Characteristics
Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
Baseline characteristics by cohort
| Measure |
Amlodipine/Valsartan 5/80 mg
n=275 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
Total
n=819 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
71.8 years
STANDARD_DEVIATION 5.01 • n=99 Participants
|
71.6 years
STANDARD_DEVIATION 5.38 • n=107 Participants
|
71.4 years
STANDARD_DEVIATION 5.44 • n=206 Participants
|
71.6 years
STANDARD_DEVIATION 5.27 • n=7 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
432 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
130 Participants
n=206 Participants
|
387 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of study (Week 8)Population: The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the Week 8 assessments, an LOCF (last observation carried forward) approach was used.
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Outcome measures
| Measure |
Amlodipine/Valsartan 5/80 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=269 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=268 Participants
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
|
-11.1 mmHg
Standard Deviation 12.68
|
-12.3 mmHg
Standard Deviation 13.23
|
-6.9 mmHg
Standard Deviation 14.00
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Outcome measures
| Measure |
Amlodipine/Valsartan 5/80 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=269 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=268 Participants
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
|
-4.2 mmHg
Standard Deviation 8.04
|
-5.3 mmHg
Standard Deviation 8.19
|
-1.7 mmHg
Standard Deviation 7.26
|
SECONDARY outcome
Timeframe: Baseline to end of study (Week 8)Population: The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
A systolic blood pressure response was defined as a msSBP \< 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Outcome measures
| Measure |
Amlodipine/Valsartan 5/80 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=269 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=268 Participants
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8
|
46.0 Percentage of patients
|
48.3 Percentage of patients
|
34.0 Percentage of patients
|
SECONDARY outcome
Timeframe: End of study (Week 8)Population: The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
Systolic blood pressure control was defined as a msSBP \< 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Outcome measures
| Measure |
Amlodipine/Valsartan 5/80 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=269 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=268 Participants
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)
|
31.3 Percentage of patients
|
37.5 Percentage of patients
|
20.5 Percentage of patients
|
SECONDARY outcome
Timeframe: End of study (Week 8)Population: The Full Analysis Set (FAS) population: All randomized patients who had a baseline and at least one post-baseline assessment an efficacy variable. For the subjects who did not complete the week 8 assessments, an LOCF (last observation carried forward) approach was used.
Overall blood pressure control was defined as a msSBP \< 140 mmHg and msDBP \< 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Outcome measures
| Measure |
Amlodipine/Valsartan 5/80 mg
n=272 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=269 Participants
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=268 Participants
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
|
30.9 Percentage of patients
|
36.4 Percentage of patients
|
19.0 Percentage of patients
|
Adverse Events
Amlodipine/Valsartan 5/80 mg
Amlodipine/Valsartan 5/40 mg
Amlodipine 5 mg
Serious adverse events
| Measure |
Amlodipine/Valsartan 5/80 mg
n=274 participants at risk
1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily
|
Amlodipine/Valsartan 5/40 mg
n=272 participants at risk
1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily
|
Amlodipine 5 mg
n=272 participants at risk
1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.36%
1/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.37%
1/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.37%
1/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.36%
1/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.37%
1/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna stage unspecified
|
0.36%
1/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.36%
1/274 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
0.00%
0/272 • 8 weeks
Adverse events (AE) could be volunteered by the subject, discovered during general questioning by the investigator, or detected through physical examination, laboratory test, or other means. Medical conditions/diseases present before starting study treatment were only considered AEs if they worsened after starting study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER