Clinical trial NCT00439738: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Obesity, hypertension, valsartan/hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 412
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline to Weeks 4, 8, 12 and 16
measure: Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)
timeFrame: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)
measure: Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)
timeFrame: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)
measure: Change From Baseline in Postprandial Glucose
timeFrame: Week 16
measure: Change From Baseline in Postprandial Insulin
timeFrame: Week 16
measure: Change From Baseline in Postprandial Non-esterified Fatty Acids
timeFrame: Week 16
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Terence T. Hart, MD
state: Alabama
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular & Hypertension
state: Oklahoma
city: Euless
country: United States
facility: Northeast Tarrant Internal Medicine Assoc
state: Texas
city: Port Orchard
country: United States
facility: Frandsen Family Medicine
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
citation: Deedwania PC, Zappe DH, Egan BM, Purkayastha D, Samuel R, Sowers JR. Does response of RAS blockade on serum K+ levels influence its glycemic-mitigating response when combined with hydrochlorothiazide? J Clin Hypertens (Greenwich). 2012 Jul;14(7):415-21. doi: 10.1111/j.1751-7176.2012.00635.x. Epub 2012 Apr 26.
citation: Ofili EO, Zappe DH, Purkayastha D, Samuel R, Sowers JR. Antihypertensive and metabolic effects of Angiotensin receptor blocker/diuretic combination therapy in obese, hypertensive African American and white patients. Am J Ther. 2013 Jan;20(1):2-12. doi: 10.1097/MJT.0b013e318230ae66.
citation: Sowers JR, Raij L, Jialal I, Egan BM, Ofili EO, Samuel R, Zappe DH, Purkayastha D, Deedwania PC. Angiotensin receptor blocker/diuretic combination preserves insulin responses in obese hypertensives. J Hypertens. 2010 Aug;28(8):1761-9. doi: 10.1097/HJH.0b013e32833af380.