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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
This study has been completed.
First Received: September 12, 2005   Last Updated: September 24, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00168779
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg
Drug: valsartan 160 mg / hydrochlorothiazide 25 mg
Drug: placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Parallel Assignment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change from baseline in mean seated trough cuff diastolic and systolic blood pressure measurements at the end of an 8-week treatment period [ Time Frame: 8 week ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 8 week ]

Estimated Enrollment: 1125
Study Start Date: September 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 in sufficiency.
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168779

  Hide Study Locations
Locations
United States, Alabama
502.476.014 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
502.476.031 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
502.476.037 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
502.476.079 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
502.476.071 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
502.476.074 Boehringer Ingelheim Investigational Site
Athens, Alabama, United States
502.476.059 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
502.476.110 Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
United States, Arizona
502.476.061 Boehringer Ingelheim Investigational Site
Glendale, Arizona, United States
United States, Arkansas
502.476.066 Boehringer Ingelheim Investigational Site
Carlisle, Arkansas, United States
United States, California
502.476.005 Boehringer Ingelheim Investigational Site
Long Beach, California, United States
502.476.029 Boehringer Ingelheim Investigational Site
Redondo Beach, California, United States
502.476.026 Boehringer Ingelheim Investigational Site
Spring Valley, California, United States
502.476.024 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
502.476.033 Boehringer Ingelheim Investigational Site
Tulsa, California, United States
502.476.048 Boehringer Ingelheim Investigational Site
Riverside, California, United States
502.476.050 Boehringer Ingelheim Investigational Site
Santa Ana, California, United States
502.476.067 Boehringer Ingelheim Investigational Site
Buena Park, California, United States
502.476.087 Boehringer Ingelheim Investigational Site
San Diego, California, United States
502.476.086 Boehringer Ingelheim Investigational Site
Encinitas, California, United States
502.476.073 Boehringer Ingelheim Investigational Site
Sacramento, California, United States
502.476.111 Boehringer Ingelheim Investigational Site
San Fransisco, California, United States
502.476.124 Boehringer Ingelheim Investigational Site
Greenbrae, California, United States
United States, Colorado
502.476.019 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
502.476.101 Boehringer Ingelheim Investigational Site
Highlands Ranch, Colorado, United States
United States, Connecticut
502.476.053 Boehringer Ingelheim Investigational Site
Farmington, Connecticut, United States
United States, Delaware
502.476.032 Boehringer Ingelheim Investigational Site
Newark, Delaware, United States
United States, Florida
502.476.012 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
502.476.015 Boehringer Ingelheim Investigational Site
Ft. Lauderdale, Florida, United States
502.476.021 Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
502.476.036 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
502.476.041 Boehringer Ingelheim Investigational Site
Coral Gables, Florida, United States
502.476.058 FPA Clinical Research
Kissimmee, Florida, United States
502.476.052 Boehringer Ingelheim Investigational Site
Largo, Florida, United States
502.476.044 Boehringer Ingelheim Investigational Site
Hollywood, Florida, United States
502.476.065 Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida, United States
502.476.080 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
502.476.108 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
United States, Georgia
502.476.008 Boehringer Ingelheim Investigational Site
Conyers, Georgia, United States
502.476.075 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
502.476.049 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
502.476.022 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
United States, Illinois
502.476.004 Boehringer Ingelheim Investigational Site
Peoria, Illinois, United States
502.476.018 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
502.476.047 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Indiana
502.476.051 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana, United States
502.476.084 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
502.476.063 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
502.476.062 Boehringer Ingelheim Investigational Site
Evansville, Indiana, United States
502.476.090 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
United States, Kansas
502.476.003 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
502.476.038 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
502.476.100 Boehringer Ingelheim Investigational Site
Newton, Kansas, United States
United States, Kentucky
502.476.002 Boehringer Ingelheim Investigational Site
Louisville, Kentucky, United States
United States, Louisiana
502.476.116 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
United States, Maryland
502.476.035 Boehringer Ingelheim Investigational Site
Oxon Hill, Maryland, United States
United States, Michigan
502.476.010 Boehringer Ingelheim Investigational Site
Troy, Michigan, United States
United States, Minnesota
502.476.028 Boehringer Ingelheim Investigational Site
Brooklyn Center, Minnesota, United States
502.476.057 Boehringer Ingelheim Investigational Site
Edina, Minnesota, United States
United States, Missouri
502.476.055 Boehringer Ingelheim Investigational Site
Kansas City, Missouri, United States
502.476.114 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, Nebraska
502.476.112 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
502.476.126 Boehringer Ingelheim Investigational Site
Omaha, Nebraska, United States
United States, Nevada
502.476.125 Boehringer Ingelheim Investigational Site
Las Vegas, Nevada, United States
United States, New Jersey
502.476.088 Boehringer Ingelheim Investigational Site
Ship Bottom, New Jersey, United States
502.476.089 Boehringer Ingelheim Investigational Site
Turnersville, New Jersey, United States
502.476.120 Boehringer Ingelheim Investigational Site
Berlin, New Jersey, United States
United States, New York
502.476.020 Boehringer Ingelheim Investigational Site
Northport, New York, United States
502.476.091 Boehringer Ingelheim Investigational Site
Williamsville, New York, United States
502.476.068 Boehringer Ingelheim Investigational Site
Brooklyn, New York, United States
502.476.025 Boehringer Ingelheim Investigational Site
Rochester, New York, United States
502.476.122 Boehringer Ingelheim Investigational Site
Hamburg, New York, United States
United States, North Carolina
502.476.027 Boehringer Ingelheim Investigational Site
Winston Salem, North Carolina, United States
502.476.042 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
502.476.046 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
502.476.083 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
502.476.095 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina, United States
United States, Ohio
502.476.016 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
502.476.023 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
502.476.034 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
502.476.060 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
502.476.064 Boehringer Ingelheim Investigational Site
Kettering, Ohio, United States
502.476.103 Boehringer Ingelheim Investigational Site
Olmstead Township, Ohio, United States
502.476.128 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
United States, Oklahoma
502.476.007 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
502.476.030 Boehringer Ingelheim Investigational Site
Tulsa, Oklahoma, United States
502.476.113 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Oregon
502.476.104 Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
United States, Pennsylvania
502.476.072 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
502.476.109 Boehringer Ingelheim Investigational Site
Erie, Pennsylvania, United States
502.476.094 Boehringer Ingelheim Investigational Site
Harleysville, Pennsylvania, United States
502.476.076 Boehringer Ingelheim Investigational Site
Springfield, Pennsylvania, United States
502.476.121 Boehringer Ingelheim Investigational Site
Penndel, Pennsylvania, United States
United States, Rhode Island
502.476.013 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
United States, Tennessee
502.476.081 Boehringer Ingelheim Investigational Site
New Tazewell, Tennessee, United States
502.476.082 Boehringer Ingelheim Investigational Site
Selmer, Tennessee, United States
502.476.085 Boehringer Ingelheim Investigational Site
Cordova, Tennessee, United States
502.476.096 Boehringer Ingelheim Investigational Site
Jackson, Tennessee, United States
United States, Texas
502.476.039 Boehringer Ingelheim Investigational Site
Carrolton, Texas, United States
502.476.056 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
502.476.069 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
502.476.070 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
502.476.107 Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
United States, Utah
502.476.017 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
502.476.006 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
502.476.001 Boehringer Ingelheim Investigational Site
Bountiful, Utah, United States
502.476.097 Boehringer Ingelheim Investigational Site
Sandy, Utah, United States
502.476.098 Boehringer Ingelheim Investigational Site
Sandy, Utah, United States
United States, Virginia
502.476.011 Boehringer Ingelheim Investigational Site
Falls Church, Virginia, United States
502.476.093 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
United States, Washington
502.476.078 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
United States, Wisconsin
502.476.105 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin, United States
502.476.106 Boehringer Ingelheim Investigational Site
Menomonee Falls, Wisconsin, United States
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.476
Study First Received: September 12, 2005
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00168779     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Benzoates
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009