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

NCT00240448 | Completed Phase 4

• 1 other identifier: 502.421
• Study Type: interventional
• Target: 1,109
• Locations: 1 country
• Sites: 100

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Percentage of responders based on change from baseline in cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period

Interventions

telmisartan 80 mg/hydrochlorothiazide 25 mg DRUG

valsartan 160 mg/hydrochlorothiazide 25 mg DRUG

placebo DRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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).
• Known or suspected secondary hypertension.
• Mean seated SBP \>= 180 mmHg or mean seated DBP \>= 120 mmHg during any clinic visit prior to randomization.
• 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.
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
• Clinically relevant hypokalemia or hyperkalemia.
• Uncorrected volume depletion.
• Uncorrected sodium depletion.
• Primary aldosteronism.
• Hereditary fructose intolerance.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (100)

Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

Boehringer Ingelheim Investigational Site

Sctoosdale, Arizona, United States

Location

Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

Boehringer Ingelheim Investigational Site

Bentonville, Arkansas, United States

Location

Boehringer Ingelheim Investigational Site

Carlisle, Arkansas, United States

Location

Boehringer Ingelheim Investigational Site

Hot Springs, Arkansas, United States

Location

Boehringer Ingelheim Investigational Site

Concord, California, United States

Location

Memorial Research Medical Clinic

Long Beach, California, United States

Location

Boehringer Ingelheim Investigational Site

Orange, California, United States

Location

Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

Clinical Trials Research

Roseville, California, United States

Location

Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

Boehringer Ingelheim Investigational Site

San Leandro, California, United States

Location

Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

Location

Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

Boehringer Ingelheim Investigational Site

Bridgeport, Connecticut, United States

Location

Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Location

Clinical Research Consultants, Inc.

Trumbull, Connecticut, United States

Location

Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Fort Myers, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Holiday, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

Christopher Chappel, MD

Kissimmee, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Largo, Florida, United States

Location

Orlando Clinical Research Center

Orlando, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

Attention: Larry I. Gilderman, D.O.

Pembroke Pines, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, United States

Location

Boehringer Ingelheim Investigational Site

Conyers, Georgia, United States

Location

Treasure Valley Cardiology

Boise, Idaho, United States

Location

Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

Cedar-Crosse Research Center

Chicago, Illinois, United States

Location

Herron Medical Center, Ltd.

Chicago, Illinois, United States

Location

Boehringer Ingelheim Investigational Site

Orland Park, Illinois, United States

Location

N Touch Research

Peoria, Illinois, United States

Location

Midwest Institute for Clinical Research Inc.

Indianapolis, Indiana, United States

Location

Boehringer Ingelheim Investigational Site

Waterloo, Iowa, United States

Location

Boehringer Ingelheim Investigational Site

Shawnee, Kansas, United States

Location

Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

Attn:William Smith

New Orleans, Louisiana, United States

Location

Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

Boehringer Ingelheim Investigational Site

Brookline, Massachusetts, United States

Location

Waltham Hospital

Waltham, Massachusetts, United States

Location

Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

Location

Boehringer Ingelheim Investigational Site

Brooklyn Center, Minnesota, United States

Location

Radiant Research

Edina, Minnesota, United States

Location

Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

Location

Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

Department of Medicine

Camden, New Jersey, United States

Location

Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

Location

Boehringer Ingelheim Investigational Site

Kingston, New York, United States

Location

Northport VAMC - Medical Service (111)

Northport, New York, United States

Location

Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

Boehringer Ingelheim Investigational Site

Scarsdale, New York, United States

Location

Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Cary, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Durham, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Stateville, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

Radiant Reseach

Cincinnati, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

Ohio State University

Columbus, Ohio, United States

Location

Radiant Research

Columbus, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Mansfield, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Mogadore, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

Bock Clinical Research

Collegeville, Pennsylvania, United States

Location

Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

Boehringer Ingelheim Investigational Site

Pottstown, Pennsylvania, United States

Location

Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

Boehringer Ingelheim Investigational Site

McKinney, Texas, United States

Location

Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

Clinical Research Center of N. VA

Falls Church, Virginia, United States

Location

Boehringer Ingelheim Investigational Site

Lacey, Washington, United States

Location

Boehringer Ingelheim Investigational Site

Lakewood, Washington, United States

Location

Boehringer Ingelheim Investigational Site

Madison, Wisconsin, United States

Location

Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: September 1, 2003
• Primary Completion: June 1, 2004
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

US (100)