Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults
Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: HCTZ + Amlodipine (Drug); Valsartan/HCTZ (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Mean Sitting Systolic Blood Pressure (MSSBP)
Secondary outcome: Change in Mean Sitting Diastolic Blood Pressure (MSDBP)Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg) Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg) Change From Baseline in Postprandial Glucose Change From Baseline in Postprandial Insulin Change From Baseline in Postprandial Non-Esterified Fatty Acids
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Terence T. Hart, MD, Muscle Shoals, Alabama 35662, United States
Westlake Medical Research, Westlake Village, California 91361, United States
Oklahoma Cardiovascular & Hypertension, Oklahoma City, Oklahoma 73132, United States
Northeast Tarrant Internal Medicine Assoc, Euless, Texas 76040, United States
Frandsen Family Medicine, Port Orchard, Washington 98366, United States
Additional Information
Starting date: December 2006
Last updated: February 9, 2009
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