Telmisartan (Micardis) and Ramipril (Altace) - Factorial Design Study for the Treatment of Hypertension

December 27, 2017 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Double-dummy, Placebo-controlled, 3x4 Factorial Design Trial to Evaluate Telmisartan 20 and 80 mg Tablets in Combination With Ramipril 1.25, 10, and 20 mg Capsules After Eight Weeks of Treatment in Patients With Stage I or II Hypertension, With an ABPM Sub-study

To identify dose combinations of telmisartan and ramipril that are more effective in reducing diastolic blood pressure than each of the respective monotherapies in patients with Stage I or II hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1354

Phase

  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina
        • 1236.1.604 Boehringer Ingelheim Investigational Site
      • Buenos Aires, Argentina
        • 1236.1.605 Boehringer Ingelheim Investigational Site
      • Buenos Aires, Argentina
        • 1236.1.610
      • Buenos Aires, Argentina
        • 1236.1.612
      • Buenos aIRES, Argentina
        • 1236.1.601 Boehringer Ingelheim Investigational Site
      • Capital Federal, Argentina
        • 1236.1.608
      • Capital Federal, Argentina
        • 1236.1.618 Hospital Ramos Mejia
      • Capital Federal,Buenos Aires, Argentina
        • 1236.1.619
      • Cordoba, Argentina
        • 1236.1.603 Boehringer Ingelheim Investigational Site
      • CordobaCordoba, Argentina
        • 1236.1.615
      • Corrientes, Argentina
        • 1236.1.611
      • Córdoba, Argentina
        • 1236.1.606
      • Córdoba, Argentina
        • 1236.1.613
      • Córdoba, Argentina
        • 1236.1.614
      • Derqui, Argentina
        • 1236.1.609
      • Mar Del Plata, Argentina
        • 1236.1.624 Instituto de Investigaciones Clínicas
      • Ramos Mejía, Argentina
        • 1236.1.620 DIM - Clinica Privada
      • Salta, Argentina
        • 1236.1.622 Hospital San Bernardo
      • Santa Fe, Argentina
        • 1236.1.621 Clinica del Torax y Especialidades
      • Zárate, Argentina
        • 1236.1.616
      • vILLA carlos paz, Argentina
        • 1236.1.602 Boehringer Ingelheim Investigational Site
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada
        • 1236.1.202 North Road Medical Centre
    • Newfoundland and Labrador
      • Bay Roberts, Newfoundland and Labrador, Canada
        • 1236.1.208 Shoppers Drug Mart Building
      • Mount Pearl, Newfoundland and Labrador, Canada
        • 1236.1.206 77 Commonwealth Avenue
      • St. John's, Newfoundland and Labrador, Canada
        • 1236.1.215 Cowan Avenue Medical Clinic
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 1236.1.203 MSHJ Research Associates
    • Ontario
      • Hamilton, Ontario, Canada
        • 1236.1.210 Hamilton Medical Research
      • Kitchener, Ontario, Canada
        • 1236.1.204 Dr. Ivan Jagas
      • Ottawa, Ontario, Canada
        • 1236.1.209 St. Joseph Cardiovascular Inc
      • Sarnia, Ontario, Canada
        • 1236.1.207 Dr. Michael O'Mahony
    • Quebec
      • Sainte-Foy, Quebec, Canada
        • 1236.1.205 Ctr. Hospital U Quebec- Pav CHUL
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 1236.1.211 Royal University Hospital
  • Chile
      • Puente Alto, Santiago De Chile, Chile
        • 1236.1.106 Hospital Dr. Sótero del Río
      • Santiago de Chile, Chile
        • 1236.1.103 Oficina 312 E (Cardiology Division)
  • Mexico
      • Acapulco Guerrero, Mexico
        • 1236.1.301 Fracc. Magallanes
      • Aguascalientes, Mexico
        • 1236.1.304 Fracc Agricultura
      • Aguascalientes, Mexico
        • 1236.1.311 Hospital de Especialidades Miguel Hidalgo
      • Col Ciudad De Sol Zapopan, Mexico
        • 1236.1.305 Especialidades Médicas del sol
      • Col. Magdalena De Las Salinas, Mexico
        • 1236.1.310 Departamento de Hemodinamia
      • Guadalajara, Mexico
        • 1236.1.307 Consultorio: Aurelio L
      • México D.F, Mexico
        • 1236.1.306
      • San Luis Potosí, Mexico
        • 1236.1.308 Hospital Central "Dr. Ignacio Morones Prieto"
      • Torreón,, Mexico
        • 1236.1.302
      • Veracruz, Mexico
        • 1236.1.303
  • Peru
      • Bella Vista, Callao,, Peru
        • 1236.1.401 Unidad de Investigacion
      • San Borja., Peru
        • 1236.1.405
      • San Isidro, Peru
        • 1236.1.402
      • San Isidro, Peru
        • 1236.1.404
      • San Isidro., Peru
        • 1236.1.403
  • United States
    • Arizona
      • Glendale, Arizona, United States
        • 1236.1.511 Boehringer Ingelheim Investigational Site
      • Tempe, Arizona, United States
        • 1236.1.574 Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • 1236.1.501 Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • 1236.1.557 Boehringer Ingelheim Investigational Site
    • California
      • Buena Park, California, United States
        • 1236.1.523 Boehringer Ingelheim Investigational Site
      • Concord, California, United States
        • 1236.1.514 Boehringer Ingelheim Investigational Site
      • Encinitas, California, United States
        • 1236.1.560 Boehringer Ingelheim Investigational Site
      • Long Beach, California, United States
        • 1236.1.573 Boehringer Ingelheim Investigational Site
      • Los Angeles, California, United States
        • 1236.1.516 Boehringer Ingelheim Investigational Site
      • Roseville, California, United States
        • 1236.1.529 Boehringer Ingelheim Investigational Site
      • Tustin, California, United States
        • 1236.1.519 Boehringer Ingelheim Investigational Site
      • Westlake Village, California, United States
        • 1236.1.543 Boehringer Ingelheim Investigational Site
    • Colorado
      • Boulder, Colorado, United States
        • 1236.1.528 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States
        • 1236.1.530 Boehringer Ingelheim Investigational Site
    • Florida
      • DeLand, Florida, United States
        • 1236.1.572 Boehringer Ingelheim Investigational Site
      • Hialeah, Florida, United States
        • 1236.1.577 Boehringer Ingelheim Investigational Site
      • Jupiter, Florida, United States
        • 1236.1.526 Boehringer Ingelheim Investigational Site
      • Largo, Florida, United States
        • 1236.1.527 Boehringer Ingelheim Investigational Site
      • Naples, Florida, United States
        • 1236.1.503 Anchor Research Center
      • New Port Richey, Florida, United States
        • 1236.1.520 Boehringer Ingelheim Investigational Site
      • Pembroke Pines, Florida, United States
        • 1236.1.571 Boehringer Ingelheim Investigational Site
    • Georgia
      • Blue Ridge, Georgia, United States
        • 1236.1.565 Boehringer Ingelheim Investigational Site
    • Idaho
      • Meridian, Idaho, United States
        • 1236.1.538 Boehringer Ingelheim Investigational Site
    • Illinois
      • Peoria, Illinois, United States
        • 1236.1.532 Boehringer Ingelheim Investigational Site
    • Indiana
      • Avon, Indiana, United States
        • 1236.1.553 Boehringer Ingelheim Investigational Site
      • Jeffersonville, Indiana, United States
        • 1236.1.546 River Cities Cardiology Research Inst of Middle America
      • Valparaiso, Indiana, United States
        • 1236.1.563 Boehringer Ingelheim Investigational Site
    • Kansas
      • Newton, Kansas, United States
        • 1236.1.517 Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, United States
        • 1236.1.531 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Richmond, Kentucky, United States
        • 1236.1.566 Boehringer Ingelheim Investigational Site
    • Maine
      • Auburn, Maine, United States
        • 1236.1.551 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Haverhill, Massachusetts, United States
        • 1236.1.536 Boehringer Ingelheim Investigational Site
      • North Dartmouth, Massachusetts, United States
        • 1236.1.576 Boehringer Ingelheim Investigational Site
      • West Yarmouth, Massachusetts, United States
        • 1236.1.561 Clinical Research Center of Cape Cod
    • Michigan
      • Cadillac, Michigan, United States
        • 1236.1.555 Boehringer Ingelheim Investigational Site
      • Troy, Michigan, United States
        • 1236.1.509 Boehringer Ingelheim Investigational Site
    • Missouri
      • Excelsior Springs, Missouri, United States
        • 1236.1.541 Boehringer Ingelheim Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States
        • 1236.1.556 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Toms River, New Jersey, United States
        • 1236.1.525 Physicians Research Center, LLC, Toms River
    • New Mexico
      • Albuquerque, New Mexico, United States
        • 1236.1.508 Boehringer Ingelheim Investigational Site
      • Albuquerque, New Mexico, United States
        • 1236.1.522 Boehringer Ingelheim Investigational Site
      • Albuquerque, New Mexico, United States
        • 1236.1.542 Boehringer Ingelheim Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States
        • 1236.1.547 Boehringer Ingelheim Investigational Site
      • Columbus, Ohio, United States
        • 1236.1.567 Boehringer Ingelheim Investigational Site
      • Kettering, Ohio, United States
        • 1236.1.515 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • 1236.1.575 Boehringer Ingelheim Investigational Site
    • Oregon
      • Corvallis, Oregon, United States
        • 1236.1.554 Boehringer Ingelheim Investigational Site
      • Eugene, Oregon, United States
        • 1236.1.524 Boehringer Ingelheim Investigational Site
      • Medford, Oregon, United States
        • 1236.1.544 Boehringer Ingelheim Investigational Site
      • Portland, Oregon, United States
        • 1236.1.545 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, United States
        • 1236.1.569 Boehringer Ingelheim Investigational Site
      • Harleysville, Pennsylvania, United States
        • 1236.1.505 Ledeeach Family Medicine
      • Tipton, Pennsylvania, United States
        • 1236.1.564 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States
        • 1236.1.534 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States
        • 1236.1.539 Boehringer Ingelheim Investigational Site
    • Texas
      • Carrollton, Texas, United States
        • 1236.1.568 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1236.1.549 Boehringer Ingelheim Investigational Site
      • Houston, Texas, United States
        • 1236.1.559 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1236.1.548 Boehringer Ingelheim Investigational Site
      • San Antonio, Texas, United States
        • 1236.1.550 Boehringer Ingelheim Investigational Site
      • The Colony, Texas, United States
        • 1236.1.570 Boehringer Ingelheim Investigational Site
    • Utah
      • Salt Lake City, Utah, United States
        • 1236.1.510 Boehringer Ingelheim Investigational Site
      • Salt Lake City, Utah, United States
        • 1236.1.513 Boehringer Ingelheim Investigational Site
      • Salt Lake City, Utah, United States
        • 1236.1.521 Boehringer Ingelheim Investigational Site
      • Sandy, Utah, United States
        • 1236.1.512 Boehringer Ingelheim Investigational Site
      • Sandy, Utah, United States
        • 1236.1.535 Boehringer Ingelheim Investigational Site
    • Virginia
      • Falls Church, Virginia, United States
        • 1236.1.502 Boehringer Ingelheim Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • 1236.1.504 Boehringer Ingelheim Investigational Site
      • Madison, Wisconsin, United States
        • 1236.1.540 Boehringer Ingelheim Investigational Site
      • Menomonee Falls, Wisconsin, United States
        • 1236.1.562 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:

  • Male and female patients >=18 years of age with Stage I or II hypertension defined as:
  • a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion Criteria:

  • Pregnant
  • breast-feeding
  • unwilling to use birth control during the study
  • secondary hypertension
  • SBP>=180 mmHg
  • DBP>=120 mmHg
  • severe renal dysfunction
  • hepatic insufficiency
  • stroke within the last 6 months
  • myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months
  • unstable or uncontrolled diabetes
  • history of angioedema of either of the study drugs, and hypersensitivity to the study drugs.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in seated trough Diastolic Blood pressure after 8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Change from baseline in systolic blood pressure after 8 weeks of treatment Percentage of patients responding to treatment Changes from baseline in diastolic and systolic blood pressure hourly means over the 24 hour dosing interval as measured by ABPM

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

April 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 25, 2006

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

  • 1236.1

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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