A Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg [Micardis HCT] Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg [Diovan HCT] Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension.

Condition(s) targeted: Hypertension

Intervention: telmisartan 80 mg / hydrochlorothiazide 25 mg (Drug); valsartan 160 mg / hydrochlorothiazide 25 mg (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients Iwth Stage 1 or Stage 2 Hypertension

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Secondary outcome: Change from baseline in seated peak (1 and 3 hours post dose) cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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:

1. are not surgically sterile; and/or

2. are nursing or pregnant

3. 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:

1. SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or

2. 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, cholestatis 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, exc

Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States

Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States

Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

Boehringer Ingelheim Investigational Site, Athens, Alabama, United States

Boehringer Ingelheim Investigational Site, Glendale, Arizona, United States

Boehringer Ingelheim Investigational Site, Carlisle, Arkansas, United States

Memorial Research Medical Clinic, Long Beach, California, United States

National Resarch Institute, Los Angeles, California, United States

Boehringer Ingelheim Investigational Site, Spring Valley, California, United States

Boehringer Ingelheim Investigational Site, Redondo Beach, California, United States

Boehringer Ingelheim Investigational Site, Tustin, California, United States

Boehringer Ingelheim Investigational Site, Riverside, California, United States

Boehringer Ingelheim Investigational Site, Santa Ana, California, United States

Boehringer Ingelheim Investigational Site, Buena Park, California, United States

Boehringer Ingelheim Investigational Site, Sacramento, California, United States

Boehringer Ingelheim Investigational Site, Encinitas, California, United States

Accelovance, San Diego, California, United States

Boehringer Ingelheim Investigational Site, San Fransisco, California, United States

Boehringer Ingelheim Investigational Site, Greenbrae, California, United States

Boehringer Ingelheim Investigational Site, Boulder, Colorado, United States

Boehringer Ingelheim Investigational Site, Highlands Ranch, Colorado, United States

University of CT Healthcare Center, Farmington, Connecticut, United States

Boehringer Ingelheim Investigational Site, Newark, Delaware, United States

Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States

Boehringer Ingelheim Investigational Site, Ft. Lauderdale, Florida, United States

Boehringer Ingelheim Investigational Site, Panama City, Florida, United States

Boehringer Ingelheim Investigational Site, Coral Gables, Florida, United States

Boehringer Ingelheim Investigational Site, Hollywood, Florida, United States

Innovative Research of Central Florida, Largo, Florida, United States

FPA Clinical Research, Kissimmee, Florida, United States

Accelovance, Melbourne, Florida, United States

Boehringer Ingelheim Investigational Site, Deland, Florida, United States

Boehringer Ingelheim Investigational Site, Conyers, Georgia, United States

Grady Memorial Hospital, Atlanta, Georgia, United States

Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States

nTouch Research Corp, Peoria, Illinois, United States

Herron Medical Center, Ltd., Chicago, Illinois, United States

Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States

Midwest Institute for Clinical Research Inc., Indianapolis, Indiana, United States

Boehringer Ingelheim Investigational Site, Evansville, Indiana, United States

Boehringer Ingelheim Investigational Site, South Bend, Indiana, United States

Compliant Clinical Research, Wichita, Kansas, United States

Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States

Boehringer Ingelheim Investigational Site, Newton, Kansas, United States

Boehringer Ingelheim Investigational Site, Louisville, Kentucky, United States

George Walker, New Orleans, Louisiana, United States

Boehringer Ingelheim Investigational Site, New Orleans, Louisiana, United States

Boehringer Ingelheim Investigational Site, Oxon Hill, Maryland, United States

Boehringer Ingelheim Investigational Site, Troy, Michigan, United States

Boehringer Ingelheim Investigational Site, Brooklyn Center, Minnesota, United States

Boehringer Ingelheim Investigational Site, Edina, Minnesota, United States

Kansas City University of Health Sciences, Kansas City, Missouri, United States

Boehringer Ingelheim Investigational Site, St. Louis, Missouri, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Creighton Diabetes Center, Omaha, Nebraska, United States

Boehringer Ingelheim Investigational Site, Las Vegas, Nevada, United States

Boehringer Ingelheim Investigational Site, Ship Bottom, New Jersey, United States

Boehringer Ingelheim Investigational Site, Turnersville, New Jersey, United States

Boehringer Ingelheim Investigational Site, Berlin, New Jersey, United States

Northport VAMC - Medical Service (111), Northport, New York, United States

University of Rochester Medical Center, Rochester, New York, United States

SUNY Downstate Medical center, Brooklyn, New York, United States

Boehringer Ingelheim Investigational Site, Williamsville, New York, United States

Boehringer Ingelheim Investigational Site, Hamburg, New York, United States

Piedmont Medical Research Associates, Winston Salem, North Carolina, United States

Boehringer Ingelheim Investigational Site, Raleigh, North Carolina, United States

Boehringer Ingelheim Investigational Site, Burlington, North Carolina, United States

Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States

Boehringer Ingelheim Investigational Site, Salisbury, North Carolina, United States

Ohio State University, Columbus, Ohio, United States

Boehringer Ingelheim Investigational Site, Columbus, Ohio, United States

Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States

Boehringer Ingelheim Investigational Site, Kettering, Ohio, United States

Boehringer Ingelheim Investigational Site, Olmstead Township, Ohio, United States

Radiant Research, Columbus, Ohio, United States

Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Tulsa, Oklahoma, United States

Radiant Research, Inc., Portland, Oregon, United States

Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Springfield, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Harleysville, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Erie, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Penndel, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, East Providence, Rhode Island, United States

Boehringer Ingelheim Investigational Site, New Tazewell, Tennessee, United States

Boehringer Ingelheim Investigational Site, Selmer, Tennessee, United States

Boehringer Ingelheim Investigational Site, Cordova, Tennessee, United States

Boehringer Ingelheim Investigational Site, Jackson, Tennessee, United States

Boehringer Ingelheim Investigational Site, Carrolton, Texas, United States

Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

Boehringer Ingelheim Investigational Site, Killeen, Texas, United States

Boehringer Ingelheim Investigational Site, Irving, Texas, United States

Boehringer Ingelheim Investigational Site, Bountiful, Utah, United States

Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States

Boehringer Ingelheim Investigational Site, Sandy, Utah, United States

Clinical Research Center of N. VA, Falls Church, Virginia, United States

Clinical Research Associates of Tidewater, Norfolk, Virginia, United States

Cedar Research LLC, Tacoma, Washington, United States

VAMC Milwaukee, Milwaukee, Wisconsin, United States

Boehringer Ingelheim Investigational Site, Menomonee Falls, Wisconsin, United States

Starting date: September 2005
Ending date: January 2007
Last updated: April 4, 2008