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Clinical Trials/NCT00005520
NCT00005520
Completed
Not Applicable

Genetic Epidemiology of Responses to Antihypertensives

Mayo Clinic1 site in 1 country1,200 target enrollmentFebruary 1997

Overview

Phase
Not Applicable
Intervention
Hydrochlorothiazide
Conditions
Cardiovascular Diseases
Sponsor
Mayo Clinic
Enrollment
1200
Locations
1
Primary Endpoint
Change in blood pressure
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

To determine whether measured variation in genes coding for components of vasoconstriction and volume regulating systems predict interindividual differences in blood pressure response to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin II receptor blocker, candesartan, in hypertensive African-Americans (N=300 treated with each drug) and in hypertensive European Americans (N=300 treated with each drug).

Detailed Description

BACKGROUND: Essential hypertension is a common disorder that contributes to morbidity, mortality, and cost of health care, especially among African-Americans. Although a single-drug therapy is commonly prescribed for treatment of hypertension, blood pressure levels are controlled in some individuals but not in others. The study has the potential to identify genes contributing to the etiology of interindividual differences in blood pressure response to diuretic therapy in African-Americans and European Americans. DESIGN NARRATIVE: Hypertensive adults were treated with the diuretic hydrochlorothiazide, 25 mg/day, for four weeks; or with the angiotensin II receptor blocker candesartan, 16 mg/day for 2 weeks followed by 32 mg/day for 4 weeks. Interindividual variations in blood pressure responses and in candidate genes coding for components of systems regulating vasoconstriction and volume were measured. In addition, a panel of 500,000 single nucleotide polymorphisms genome-wide was measured in subsets of the most extreme responders and nonresponders to each drug for genome-wide association of analyses.

Registry
clinicaltrials.gov
Start Date
February 1997
End Date
January 2008
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen T. Turner

Professor of Medicine

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

African American hydrochlorothiazide

300 African American hypertensives were treated with hydrochlorothiazide 25 mg daily for 4 weeks.

Intervention: Hydrochlorothiazide

European American hydrochlorothiazide

300 European American hypertensives were treated with hydrochlorothiazide 25 mg daily for 4 weeks

Intervention: Hydrochlorothiazide

African American candesartan

300 African American hypertensives were treated with candesartan 16 mg daily for 2 weeks followed by 32 mg daily for 4 weeks

Intervention: Candesartan

European American candesartan

300 European American hypertensives were treated with candesartan 16 mg daily for 2 weeks followed by 32 mg daily for 4 weeks

Intervention: Candesartan

Outcomes

Primary Outcomes

Change in blood pressure

Time Frame: 4 weeks for hydrochlorothiazide; 6 weeks for candesartan

The blood pressure response to antihypertensive drug therapy was defined by the difference between blood pressure levels prior to and at the end of drug therapy.

Secondary Outcomes

  • Adverse metabolic changes(4 weeks for hydrochlorothiazide only)

Study Sites (1)

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