PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)

December 6, 2013 updated by: Boehringer Ingelheim

A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined With Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets With Losartan Combined With Hydrochlorothiazide (50 mg/12.5 mg) Tablets Using Ambulatory Blood Pressure Monitoring in Patients With Mild-to-Moderate Hypertension

To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.

Study Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

805

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
  - Huntsville, Alabama, United States
    - Boehringer Ingelheim Investigational Site
- Arkansas
  - Little Rock, Arkansas, United States
    - Research Solutions, LLC
- California
  - Carmichael, California, United States
    - Boehringer Ingelheim Investigational Site
  - Concord, California, United States
    - Boehringer Ingelheim Investigational Site
  - Fresno, California, United States
    - Sierra Medical Research
  - Long Beach, California, United States
    - Attn: Ginger Paselk
  - Orange, California, United States
    - Boehringer Ingelheim Investigational Site
  - Orangevale, California, United States
    - DeBruin Medical Center
  - Roseville, California, United States
    - Clinical Trials Research
  - Sacramento, California, United States
    - Dr. R. David Ferrera
  - Westlake Village, California, United States
    - Westlake Medical Research
- Colorado
  - Wheat Ridge, Colorado, United States
    - Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
- Connecticut
  - Trumbull, Connecticut, United States
    - Clinical Research Consultants, Inc.
- Delaware
  - Newark, Delaware, United States
    - Glasgow Family Pract6ice
- Florida
  - Coral Gables, Florida, United States
    - Boehringer Ingelheim Investigational Site
  - Coral Gables, Florida, United States
    - Miami Research Associates
  - Hollywood, Florida, United States
    - Patron, Andres, D.O.
  - Kissimmee, Florida, United States
    - Christopher Chappel, MD
  - Melbourne, Florida, United States
    - Boehringer Ingelheim Investigational Site
  - Orlando, Florida, United States
    - Orlando Clinical Research Center
  - Pembroke Pines, Florida, United States
    - Attention: Larry I. Gilderman, D.O.
  - St. Petersburg, Florida, United States
    - nTouch Research
  - Tampa, Florida, United States
    - Tampa Medical Research Associates
- Georgia
  - Augusta, Georgia, United States
    - Southern Clinical Research and Management, Inc.
  - Conyers, Georgia, United States
    - Boehringer Ingelheim Investigational Site
- Idaho
  - Boise, Idaho, United States
    - Treasure Valley Cardiology
- Illinois
  - Chicago, Illinois, United States
    - Cedar-Crosse Research Center
  - Chicago, Illinois, United States
    - Herron Medical Center, Ltd.
  - Elk Grove Village, Illinois, United States
    - Protococare Trials, Inc.
  - Peoria, Illinois, United States
    - N Touch Research
- Indiana
  - Indianapolis, Indiana, United States
    - Midwest Institute for Clinical Research Inc.
- Kansas
  - Overland, Kansas, United States
    - Radiant Research
- Maryland
  - Oxon Hill, Maryland, United States
    - Ong Medical Center
- Minnesota
  - Edina, Minnesota, United States
    - Radiant Research
  - St. Paul, Minnesota, United States
    - Cardiology Research
- Missouri
  - Florissant, Missouri, United States
    - Attention: Mel E. Lucas, DO
- New Mexico
  - Alburquerque, New Mexico, United States
    - New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
- New York
  - Syracuse, New York, United States
    - Syracuse Preventative Cardiology
  - Westfield, New York, United States
    - Great Lakes Medical Research
  - Williamsville, New York, United States
    - Cardiology and Internal Medicine- Williamsville NY
- North Carolina
  - Berlin, North Carolina, United States
    - Comprehensive Clinical Research
  - Charlotte, North Carolina, United States
    - Bennett Cardiac Center
  - Charlotte, North Carolina, United States
    - Charlotte Clinical Research
  - Raleigh, North Carolina, United States
    - Boehringer Ingelheim Investigational Site
  - Raleigh, North Carolina, United States
    - nTouch Research Corporation
  - Winston Salem, North Carolina, United States
    - Piedmont Research Associates
  - Winston Salem, North Carolina, United States
    - Wake Forest University School of Medicine
- Ohio
  - Cincinnati, Ohio, United States
    - Boehringer Ingelheim Investigational Site
  - Cincinnati, Ohio, United States
    - Radiant Reseach
  - Columbus, Ohio, United States
    - Radiant Research
- Oklahoma
  - Oklahoma City, Oklahoma, United States
    - Boehringer Ingelheim Investigational Site
  - Oklahoma City, Oklahoma, United States
    - nTouch
  - Tulsa, Oklahoma, United States
    - Hillcrest Medical Center
- Pennsylvania
  - Collegeville, Pennsylvania, United States
    - Bock Clinical Research
  - Downingtown, Pennsylvania, United States
    - Bock Clinical Research
  - Harleysville, Pennsylvania, United States
    - Bock Clinical Research
  - Pittsburgh, Pennsylvania, United States
    - The Western Pennsylvania Hospital
- Rhode Island
  - Warwick, Rhode Island, United States
    - Omega Research
- Tennessee
  - Knoxville, Tennessee, United States
    - University of Tennessee Medical Center
  - Memphis, Tennessee, United States
    - Veterans Affairs Medical Center
  - Nashville, Tennessee, United States
    - Clinical Research Associates, Inc.
- Texas
  - Dallas, Texas, United States
    - Boehringer Ingelheim Investigational Site
  - Houston, Texas, United States
    - nTouch Research
- Virginia
  - Hampton, Virginia, United States
    - Hampton Roads Medical Specialists
  - Norfolk, Virginia, United States
    - 885 Kempsville Road, Suite 221
  - Norfolk, Virginia, United States
    - York Clinical Research
  - Richmond, Virginia, United States
    - Boehringer Ingelheim Investigational Site
- Wisconsin
  - Madison, Wisconsin, United States
    - Gemini Scientific
  - Madison, Wisconsin, United States
    - University of Wisconsin Medical School

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Ability to provide written informed consent in accordance with GCP and local legislation.
Mild-to-moderate hypertension defined as a mean seated DBP of >= 95 mm Hg and <=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
Male or Female >= 18 years.
Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
24-hour ABPM mean DBP of >= 85 mm Hg at Visit 3.

Exclusion Criteria:

Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who
- are not surgically sterile, or are
- nursing, or
- are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do not plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. No exception will be made.
Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
Mean seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.
Known or suspected secondary hypertension (i.e. pheochromocytoma).
Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (>203 mico mol/l).
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
Biliary obstructive disorders.
Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
Uncorrected volume depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Congestive heart failure (NYHA functional class CHF III-IV).
Unstable angina within the past 3 months prior to signing the informed consent form.
Stroke within the past 6 months prior to signing the informed consent form.
Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to signing the informed consent form.
Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past 3 months as defined by an HbA1C >= 10 Percent.
Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
Any investigational therapy within 1 month of signing the informed consent form.
Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
History of non-compliance with prescribed medication.
Inability to comply with protocol.

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
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring) Time Frame: after 6 Weeks	after 6 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP) Time Frame: after 6 weeks	after 6 weeks
Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP Time Frame: after 6 weeks	after 6 weeks
Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval Time Frame: after 6 weeks	after 6 weeks
Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval Time Frame: after 6 weeks	after 6 weeks
Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer Time Frame: after 6 weeks	after 6 weeks
Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements Time Frame: after 6 weeks	after 6 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

July 1, 2002

Primary Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria