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

NCT00439738 | Completed Phase 4 Results

• 1 other identifier: CVAH631BUS06
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 5

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.

Conditions

Hypertension

Keywords

Obesity, hypertension, valsartan/hydrochlorothiazide

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Systolic Blood Pressure (MSSBP)

  Baseline to Week 8

Secondary Outcomes (6)

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP)

  Baseline to Weeks 4, 8, 12 and 16

• Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)

  Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)

• Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)

  Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)

• Change From Baseline in Postprandial Glucose

  Week 16

• Change From Baseline in Postprandial Insulin

  Week 16

Study Arms (2)

valsartan/HCTZ

EXPERIMENTAL

Drug: Valsartan/HCTZ

HCTZ +Amlodipine

ACTIVE COMPARATOR

Drug: HCTZ + Amlodipine

Interventions

HCTZ + Amlodipine DRUG

* 12.5 mg HCTZ capsules * 25 mg HCTZ capsules * 5 mg amlodipine capsules * 10 mg amlodipine capsules

HCTZ +Amlodipine

Valsartan/HCTZ DRUG

* 160 mg film-coated valsartan tablets * 320 mg film-coated valsartan tablets * 12.5 mg HCTZ capsules * 25 mg HCTZ capsules

valsartan/HCTZ

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Terence T. Hart, MD

Muscle Shoals, Alabama, 35662, United States

Location

Westlake Medical Research

Westlake Village, California, 91361, United States

Location

Oklahoma Cardiovascular & Hypertension

Oklahoma City, Oklahoma, 73132, United States

Location

Northeast Tarrant Internal Medicine Assoc

Euless, Texas, 76040, United States

Location

Frandsen Family Medicine

Port Orchard, Washington, 98366, United States

Location

Related Publications (3)

• 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.

  PMID: 22747613 DERIVED

• 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.

  PMID: 22248871 DERIVED

• 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.

  PMID: 20498618 DERIVED

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

1-862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 23, 2007
• First Posted: February 26, 2007
• Study Start: December 1, 2006
• Primary Completion: November 1, 2007
• Last Updated: May 16, 2017
• Results First Posted: February 10, 2009

Record last verified: 2017-04

Locations

US (5)