Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension

NCT00168779 | Completed Phase 4

• 1 other identifier: 502.476
• Study Type: interventional
• Target: 1,185
• Locations: 1 country
• Sites: 113

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)

• Mean seated trough cuff DBP and SBP

  after 8 week

Secondary Outcomes (3)

• The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements

  after 8 week

• The percentage of patients with uncontrolled hypertension

  after 8 weeks

• Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points

  after 8 weeks

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 (113)

502.476.074 Boehringer Ingelheim Investigational Site

Athens, Alabama, United States

Location

502.476.059 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

502.476.071 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

502.476.079 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

502.476.014 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

502.476.031 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

502.476.110 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

502.476.037 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

502.476.061 Boehringer Ingelheim Investigational Site

Glendale, Arizona, United States

Location

502.476.066 Boehringer Ingelheim Investigational Site

Carlisle, Arkansas, United States

Location

502.476.067 Boehringer Ingelheim Investigational Site

Buena Park, California, United States

Location

502.476.086 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

502.476.124 Boehringer Ingelheim Investigational Site

Greenbrae, California, United States

Location

502.476.005 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

502.476.024 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

502.476.029 Boehringer Ingelheim Investigational Site

Redondo Beach, California, United States

Location

502.476.048 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

502.476.073 Boehringer Ingelheim Investigational Site

Sacramento, California, United States

Location

502.476.087 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

502.476.111 Boehringer Ingelheim Investigational Site

San Francisco, California, United States

Location

502.476.050 Boehringer Ingelheim Investigational Site

Santa Ana, California, United States

Location

502.476.026 Boehringer Ingelheim Investigational Site

Spring Valley, California, United States

Location

502.476.033 Boehringer Ingelheim Investigational Site

Tulsa, California, United States

Location

502.476.019 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Location

502.476.101 Boehringer Ingelheim Investigational Site

Highlands Ranch, Colorado, United States

Location

502.476.053 Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Location

502.476.032 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

502.476.041 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

502.476.108 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

502.476.015 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

502.476.044 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

502.476.058 FPA Clinical Research

Kissimmee, Florida, United States

Location

502.476.052 Boehringer Ingelheim Investigational Site

Largo, Florida, United States

Location

502.476.080 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Location

502.476.021 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

502.476.012 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

502.476.036 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

502.476.065 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

502.476.022 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

502.476.049 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

502.476.008 Boehringer Ingelheim Investigational Site

Conyers, Georgia, United States

Location

502.476.075 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

502.476.018 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

502.476.047 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

502.476.004 Boehringer Ingelheim Investigational Site

Peoria, Illinois, United States

Location

502.476.062 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

502.476.063 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

502.476.051 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

502.476.084 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Location

502.476.090 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Location

502.476.100 Boehringer Ingelheim Investigational Site

Newton, Kansas, United States

Location

502.476.003 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

502.476.038 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

502.476.002 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

Location

502.476.116 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

502.476.035 Boehringer Ingelheim Investigational Site

Oxon Hill, Maryland, United States

Location

502.476.010 Boehringer Ingelheim Investigational Site

Troy, Michigan, United States

Location

502.476.028 Boehringer Ingelheim Investigational Site

Brooklyn Center, Minnesota, United States

Location

502.476.057 Boehringer Ingelheim Investigational Site

Edina, Minnesota, United States

Location

502.476.055 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

502.476.114 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

502.476.112 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

502.476.126 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

502.476.125 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

502.476.120 Boehringer Ingelheim Investigational Site

Berlin, New Jersey, United States

Location

502.476.088 Boehringer Ingelheim Investigational Site

Ship Bottom, New Jersey, United States

Location

502.476.089 Boehringer Ingelheim Investigational Site

Turnersville, New Jersey, United States

Location

502.476.068 Boehringer Ingelheim Investigational Site

Brooklyn, New York, United States

Location

502.476.122 Boehringer Ingelheim Investigational Site

Hamburg, New York, United States

Location

502.476.020 Boehringer Ingelheim Investigational Site

Northport, New York, United States

Location

502.476.025 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

502.476.091 Boehringer Ingelheim Investigational Site

Williamsville, New York, United States

Location

502.476.046 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Location

502.476.083 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

502.476.042 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

502.476.095 Boehringer Ingelheim Investigational Site

Salisbury, North Carolina, United States

Location

502.476.027 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

502.476.034 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

502.476.060 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

502.476.016 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

502.476.023 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

502.476.128 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

502.476.064 Boehringer Ingelheim Investigational Site

Kettering, Ohio, United States

Location

502.476.103 Boehringer Ingelheim Investigational Site

Olmsted Falls, Ohio, United States

Location

502.476.007 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

502.476.113 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

502.476.030 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

502.476.104 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

502.476.109 Boehringer Ingelheim Investigational Site

Erie, Pennsylvania, United States

Location

502.476.094 Boehringer Ingelheim Investigational Site

Harleysville, Pennsylvania, United States

Location

502.476.121 Boehringer Ingelheim Investigational Site

Penndel, Pennsylvania, United States

Location

502.476.072 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

502.476.076 Boehringer Ingelheim Investigational Site

Springfield, Pennsylvania, United States

Location

502.476.013 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

502.476.085 Boehringer Ingelheim Investigational Site

Cordova, Tennessee, United States

Location

502.476.096 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

Location

502.476.081 Boehringer Ingelheim Investigational Site

New Tazewell, Tennessee, United States

Location

502.476.082 Boehringer Ingelheim Investigational Site

Selmer, Tennessee, United States

Location

502.476.039 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

502.476.056 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

502.476.069 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

502.476.107 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

502.476.070 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

502.476.001 Boehringer Ingelheim Investigational Site

Bountiful, Utah, United States

Location

502.476.006 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

502.476.017 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

502.476.097 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Location

502.476.098 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Location

502.476.011 Boehringer Ingelheim Investigational Site

Falls Church, Virginia, United States

Location

502.476.093 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

502.476.078 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

502.476.106 Boehringer Ingelheim Investigational Site

Menomonee Falls, Wisconsin, United States

Location

502.476.105 Boehringer Ingelheim Investigational Site

Milwaukee, Wisconsin, United States

Location

Related Links

• Related Info

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

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

US (113)