Trial Outcomes & Findings for Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults (NCT NCT00439738)
NCT ID: NCT00439738
Last Updated: 2017-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
412 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2017-05-16
Participant Flow
Participant milestones
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
|
HCTZ +Amlodipine
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
206
|
|
Overall Study
COMPLETED
|
170
|
178
|
|
Overall Study
NOT COMPLETED
|
36
|
28
|
Reasons for withdrawal
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
|
HCTZ +Amlodipine
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
13
|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
6
|
|
Overall Study
Protocol Violation
|
6
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Abnormal Lab Values
|
1
|
0
|
Baseline Characteristics
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
Baseline characteristics by cohort
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=206 Participants
|
HCTZ +Amlodipine
n=206 Participants
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
172 participants
83.5 • n=99 Participants
|
180 participants
87.4 • n=107 Participants
|
352 participants
85.4 • n=206 Participants
|
|
Age, Customized
>=65 years
|
34 participants
16.5 • n=99 Participants
|
26 participants
12.6 • n=107 Participants
|
60 participants
14.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
272 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Baseline
|
159.7 mm Hg
Standard Deviation 7.81
|
159.0 mm Hg
Standard Deviation 7.62
|
|
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Week 8
|
131.2 mm Hg
Standard Deviation 16.26
|
137.5 mm Hg
Standard Deviation 13.52
|
|
Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Change from baseline
|
-28.6 mm Hg
Standard Deviation 15.61
|
-21.5 mm Hg
Standard Deviation 12.58
|
SECONDARY outcome
Timeframe: Baseline to Weeks 4, 8, 12 and 16Population: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Change from baseline to week 16
|
-14.0 mm Hg
Standard Deviation 9.90
|
-12.7 mm Hg
Standard Deviation 8.35
|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Baseline
|
94.9 mm Hg
Standard Deviation 7.94
|
93.6 mm Hg
Standard Deviation 8.18
|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 4
|
85.7 mm Hg
Standard Deviation 9.38
|
87.6 mm Hg
Standard Deviation 9.20
|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 8
|
81.9 mm Hg
Standard Deviation 9.87
|
85.1 mm Hg
Standard Deviation 8.54
|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 12
|
81.1 mm Hg
Standard Deviation 9.14
|
82.8 mm Hg
Standard Deviation 8.75
|
|
Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
Week 16
|
80.8 mm Hg
Standard Deviation 10.14
|
80.9 mm Hg
Standard Deviation 8.66
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)Population: Intent to Treat (ITT)
Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 140/90 mm Hg
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Week 4
|
91 participants
|
69 participants
|
|
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Week 8
|
123 participants
|
102 participants
|
|
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Week 12
|
122 participants
|
112 participants
|
|
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
Week 16
|
124 participants
|
140 participants
|
|
Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
End of study
|
133 participants
|
146 participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)Population: Intent to Treat (ITT)
Mean sitting systolic blood pressure/mean sitting diastolic blood pressure \< 130/80 mm Hg
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Week 4
|
33 participants
|
18 participants
|
|
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Week 8
|
59 participants
|
23 participants
|
|
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Week 12
|
57 participants
|
46 participants
|
|
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
Week 16
|
62 participants
|
65 participants
|
|
Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
End of Study
|
68 participants
|
68 participants
|
SECONDARY outcome
Timeframe: Week 16Population: Only those patients who completed the study through week 16 were included in this analysis.
After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Change From Baseline in Postprandial Glucose
Baseline visit (0 minutes)
|
98.0 mg/dL
Standard Deviation 15.91
|
99.4 mg/dL
Standard Deviation 19.12
|
|
Change From Baseline in Postprandial Glucose
Week 16 (0 minutes)
|
98.1 mg/dL
Standard Deviation 15.68
|
102.8 mg/dL
Standard Deviation 17.81
|
|
Change From Baseline in Postprandial Glucose
Change from baseline to week 16 (0 minutes)
|
-0.5 mg/dL
Standard Deviation 13.71
|
3.4 mg/dL
Standard Deviation 18.28
|
|
Change From Baseline in Postprandial Glucose
Baseline visit (120 minutes)
|
123.9 mg/dL
Standard Deviation 47.18
|
127.7 mg/dL
Standard Deviation 40.30
|
|
Change From Baseline in Postprandial Glucose
Week 16 (120 minutes)
|
126.3 mg/dL
Standard Deviation 49.52
|
146.5 mg/dL
Standard Deviation 56.51
|
|
Change From Baseline in Postprandial Glucose
Change from baseline to week 16 (120 minutes)
|
2.1 mg/dL
Standard Deviation 38.21
|
18.9 mg/dL
Standard Deviation 40.88
|
SECONDARY outcome
Timeframe: Week 16Population: Only those patients who completed the study through week 16 were included in this analysis
After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Change From Baseline in Postprandial Insulin
Baseline visit (0 minutes)
|
19.66 mg/dL
Standard Deviation 20.435
|
20.37 mg/dL
Standard Deviation 20.583
|
|
Change From Baseline in Postprandial Insulin
Week 16 (0 minutes)
|
23.45 mg/dL
Standard Deviation 26.039
|
23.62 mg/dL
Standard Deviation 19.267
|
|
Change From Baseline in Postprandial Insulin
Change from baseline to week 16 (0 minutes)
|
3.41 mg/dL
Standard Deviation 28.427
|
3.67 mg/dL
Standard Deviation 19.170
|
|
Change From Baseline in Postprandial Insulin
Baseline visit (120 minutes)
|
92.04 mg/dL
Standard Deviation 82.183
|
95.95 mg/dL
Standard Deviation 76.483
|
|
Change From Baseline in Postprandial Insulin
Week 16 (120 minutes)
|
116.04 mg/dL
Standard Deviation 129.880
|
120.01 mg/dL
Standard Deviation 100.302
|
|
Change From Baseline in Postprandial Insulin
Change from baseline to week 16 (120 minute)
|
24.68 mg/dL
Standard Deviation 90.094
|
28.07 mg/dL
Standard Deviation 71.674
|
SECONDARY outcome
Timeframe: Week 16Population: Only those patients who completed the study through week 16 were included in this analysis
After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test
Outcome measures
| Measure |
Valsartan/HCTZ (Hydrochlorothiazide)
n=197 Participants
|
HCTZ +Amlodipine
n=204 Participants
|
|---|---|---|
|
Change From Baseline in Postprandial Non-esterified Fatty Acids
Baseline visit (0 minutes)
|
0.45 mg/dL
Standard Deviation 0.208
|
0.47 mg/dL
Standard Deviation 0.318
|
|
Change From Baseline in Postprandial Non-esterified Fatty Acids
Week 16 (0 minutes)
|
0.46 mg/dL
Standard Deviation 0.194
|
0.47 mg/dL
Standard Deviation 0.196
|
|
Change From Baseline in Postprandial Non-esterified Fatty Acids
Change from baseline to week 16 (0 minutes)
|
0.01 mg/dL
Standard Deviation 0.249
|
0.00 mg/dL
Standard Deviation 0.341
|
|
Change From Baseline in Postprandial Non-esterified Fatty Acids
Baseline visit (120 minutes)
|
0.11 mg/dL
Standard Deviation 0.090
|
0.10 mg/dL
Standard Deviation 0.116
|
|
Change From Baseline in Postprandial Non-esterified Fatty Acids
Week 16 (120 minutes)
|
0.10 mg/dL
Standard Deviation 0.093
|
0.10 mg/dL
Standard Deviation 0.056
|
|
Change From Baseline in Postprandial Non-esterified Fatty Acids
Change from baseline to week 16 (120 minutes)
|
-0.01 mg/dL
Standard Deviation 0.117
|
-0.01 mg/dL
Standard Deviation 0.120
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 1-862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER