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A Randomized, Double-blind, Placebo Controlled Comparison of Telmisartan Hydrochlorothiazide (HCT) and Valsartan HCT in Hypertension (HTN) Stage I/II Patients

NCT ID: NCT00240448

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Brief Summary

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The primary objective of this study is to compare the effectiveness of telmisartan 80 mg/hydrochlorothiazide 25 mg \[Micardis HCT\] to valsartan 160 mg/hydrochlorothiazide 25 mg \[Diovan HCT\] and placebo in the treatment of Stage 1 and Stage 2 hypertension.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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telmisartan 80 mg/hydrochlorothiazide 25 mg

Intervention Type DRUG

valsartan 160 mg/hydrochlorothiazide 25 mg

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Ability to provide written informed consent.
2. Age 18 years or older.
3. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion).
4. Seated cuff DBP of 95 mmHg at Visit 2 (baseline).

Exclusion Criteria

1. Pre-menopausal women (last menstruation 1 year prior to start of run-in period) who:

* Are not surgically sterile and/or
* Are nursing or pregnant
* Are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of \> 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
2. Known or suspected secondary hypertension.
3. Mean seated SBP \>= 180 mmHg or mean seated DBP \>= 120 mmHg during any clinic visit prior to randomization.
4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

* SGPT (ALT) or SGOT (AST) \> 2 times the upper limit of normal range, or
* Serum creatinine \> 3.0 mg/dL or creatinine clearance \< 0.6 ml/sec.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
6. Clinically relevant hypokalemia or hyperkalemia.
7. Uncorrected volume depletion.
8. Uncorrected sodium depletion.
9. Primary aldosteronism.
10. Hereditary fructose intolerance.
11. Biliary obstructive disorders, cholestasis or moderate to severe hepatic insufficiency.
12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
13. History of drug or alcohol dependency within six months prior to start of run-in period.
14. Chronic administration of any medications known to affect blood pressure, etc.
15. Any investigational drug therapy within one month of start of run-in period.
16. known hypersensitivity to any component of the formulation study drugs (telmisartan, valsartan, HCT).
17. Contra-indication to a placebo run-in period (e.g. stroke within the past six months, MI, cardia surgery, PTCA or angina within the past three months prior to the start of run-in period.
18. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of telmisartan, valsartan, or HCT.
19. Night shift workers.
20. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
21. NYHA functional class CHF III-IV.
22. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
23. Patients whose diabetes has been unstable and uncontrolled for at least the past 3 months as defined by a HbA1c \>/= 10%.
24. Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCT).
25. History of non-compliance with prescribed medication or protocol procedures.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

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Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

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Boehringer Ingelheim Investigational Site

Sctoosdale, Arizona, United States

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Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

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Boehringer Ingelheim Investigational Site

Bentonville, Arkansas, United States

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Boehringer Ingelheim Investigational Site

Carlisle, Arkansas, United States

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Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

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Boehringer Ingelheim Investigational Site

Concord, California, United States

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Memorial Research Medical Clinic

Long Beach, California, United States

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Boehringer Ingelheim Investigational Site

Orange, California, United States

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Boehringer Ingelheim Investigational Site

Riverside, California, United States

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Clinical Trials Research

Roseville, California, United States

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Boehringer Ingelheim Investigational Site

Sacramento, California, United States

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Boehringer Ingelheim Investigational Site

San Leandro, California, United States

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Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

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Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

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Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

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Boehringer Ingelheim Investigational Site

Torrance, California, United States

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Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

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Boehringer Ingelheim Investigational Site

Bridgeport, Connecticut, United States

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Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

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Clinical Research Consultants, Inc.

Trumbull, Connecticut, United States

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Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

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Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

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Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

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Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

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Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

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Boehringer Ingelheim Investigational Site

Holiday, Florida, United States

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Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

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Christopher Chappel, MD

Kissimmee, Florida, United States

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Boehringer Ingelheim Investigational Site

Largo, Florida, United States

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Orlando Clinical Research Center

Orlando, Florida, United States

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Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

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Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

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Attention: Larry I. Gilderman, D.O.

Pembroke Pines, Florida, United States

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Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

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Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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Grady Memorial Hospital

Atlanta, Georgia, United States

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Boehringer Ingelheim Investigational Site

Conyers, Georgia, United States

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Treasure Valley Cardiology

Boise, Idaho, United States

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Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

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Cedar-Crosse Research Center

Chicago, Illinois, United States

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Herron Medical Center, Ltd.

Chicago, Illinois, United States

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Boehringer Ingelheim Investigational Site

Orland Park, Illinois, United States

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N Touch Research

Peoria, Illinois, United States

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Midwest Institute for Clinical Research Inc.

Indianapolis, Indiana, United States

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Boehringer Ingelheim Investigational Site

Waterloo, Iowa, United States

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Boehringer Ingelheim Investigational Site

Shawnee, Kansas, United States

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Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

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Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

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Attn:William Smith

New Orleans, Louisiana, United States

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Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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Boehringer Ingelheim Investigational Site

Brookline, Massachusetts, United States

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Waltham Hospital

Waltham, Massachusetts, United States

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Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

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Boehringer Ingelheim Investigational Site

Brooklyn Center, Minnesota, United States

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Radiant Research

Edina, Minnesota, United States

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Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

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Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

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Department of Medicine

Camden, New Jersey, United States

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Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

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Boehringer Ingelheim Investigational Site

Kingston, New York, United States

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Northport VAMC - Medical Service (111)

Northport, New York, United States

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Boehringer Ingelheim Investigational Site

Rochester, New York, United States

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Boehringer Ingelheim Investigational Site

Scarsdale, New York, United States

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Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

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Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Cary, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Stateville, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

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Radiant Reseach

Cincinnati, Ohio, United States

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Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

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Ohio State University

Columbus, Ohio, United States

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Radiant Research

Columbus, Ohio, United States

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Boehringer Ingelheim Investigational Site

Mansfield, Ohio, United States

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Boehringer Ingelheim Investigational Site

Mogadore, Ohio, United States

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Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

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Bock Clinical Research

Collegeville, Pennsylvania, United States

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Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

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Boehringer Ingelheim Investigational Site

Pottstown, Pennsylvania, United States

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Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

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Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

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Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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Boehringer Ingelheim Investigational Site

Austin, Texas, United States

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Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

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Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

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Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

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Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

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Clinical Research Center of N. VA

Falls Church, Virginia, United States

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Boehringer Ingelheim Investigational Site

Lacey, Washington, United States

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Boehringer Ingelheim Investigational Site

Lakewood, Washington, United States

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Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

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Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

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Countries

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United States

Other Identifiers

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502.421

Identifier Type: -

Identifier Source: org_study_id