Phase 4
Completed N=412
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
Source: ClinicalTrials.gov NCT00439738 ↗Enrolled (actual)
412
Serious AEs
—
Results posted
Feb 2009
Primary outcomePrimary: Change in Mean Sitting Systolic Blood Pressure (MSSBP) — 159.7; 159.0; 131.2; 137.5 mm Hg
Summary
The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Sitting Systolic Blood Pressure (MSSBP) |
159.7; 159.0; 131.2; 137.5; -28.6; -21.5 | — |
| SECONDARY Change in Mean Sitting Diastolic Blood Pressure (MSDBP) |
94.9; 93.6; 85.7; 87.6; 81.9; 85.1 | — |
| SECONDARY Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg) |
91; 69; 123; 102; 122; 112 | — |
| SECONDARY Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg) |
33; 18; 59; 23; 57; 46 | — |
| SECONDARY Change From Baseline in Postprandial Glucose |
98.0; 99.4; 98.1; 102.8; -0.5; 3.4 | — |
| SECONDARY Change From Baseline in Postprandial Insulin |
19.66; 20.37; 23.45; 23.62; 3.41; 3.67 | — |
| SECONDARY Change From Baseline in Postprandial Non-esterified Fatty Acids |
0.45; 0.47; 0.46; 0.47; 0.01; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- 40 years of age or older
- Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg
- Central (abdominal) obesity
Exclusion Criteria
- Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg
- Currently taking more then 3 medications to treat high blood pressure
- Inability to stop all current blood pressure medications if any up to 4 weeks
- History of Type 1 or Type 2 diabetes
- History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months
- History of or current diagnosis of congestive heart failure
- History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma
- Women who are pregnant or nursing
- Alcohol or drug abuse within the last 2 years
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00439738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.