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

December 27, 2017 updated by: Boehringer Ingelheim

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 With Stage 1 or Stage 2 Hypertension.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1185

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean seated trough cuff DBP and SBP
Time Frame: after 8 week
after 8 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements
Time Frame: after 8 week
after 8 week
The percentage of patients with uncontrolled hypertension
Time Frame: after 8 weeks
after 8 weeks
Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points
Time Frame: after 8 weeks
after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 27, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.476

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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