Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

Official Title: “A 16-Week Double-Blind, Randomized, Multicenter, Force-Titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients”

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.

Intervention(s) in this Clinical Trial

• Drug: HCTZ + Amlodipine
  • 12.5 mg HCTZ capsules 25 mg HCTZ capsules 5 mg amlodipine capsules 10 mg amlodipine capsules
• Drug: Valsartan/HCTZ
  • 160 mg film-coated valsartan tablets 320 mg film-coated valsartan tablets 12.5 mg HCTZ capsules 25 mg HCTZ capsules

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: valsartan/HCTZ
• Active Comparator: HCTZ +Amlodipine

Primary Measures

• Change in Mean Sitting Systolic Blood Pressure (MSSBP)
  • Time Frame: Baseline to Week 8
    Safety Issue?: No

Secondary Measures

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
  • Time Frame: Baseline to Weeks 4, 8, 12 and 16
    Safety Issue?: No
• Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
  • Time Frame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)
    Safety Issue?: No
• Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
  • Time Frame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)
    Safety Issue?: No
• Change From Baseline in Postprandial Glucose
  • Time Frame: Week 16
    Safety Issue?: No
• Change From Baseline in Postprandial Insulin
  • Time Frame: Week 16
    Safety Issue?: No
• Change From Baseline in Postprandial Non-Esterified Fatty Acids
  • Time Frame: Week 16
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00439738

Study ID Number: CVAH631BUS06

ClinicalTrials.gov Identifier: NCT00439738

Health Authority: United States: Food and Drug Administration