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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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)

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

NCT00274638•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to provide written informed consent in accordance with GCP and local legislation.
•2. 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.
•3. Male or Female \>= 18 years.
•4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
•5. 24-hour ABPM mean DBP of \>= 85 mm Hg at Visit 3.

Exclusion Criteria

•1. 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.
•2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
•3. Mean seated SBP \>= 180 mm Hg or mean seated DBP \>= 110 mm Hg during any visit or the placebo run-in phase.
•4. Known or suspected secondary hypertension (i.e. pheochromocytoma).
•5. 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).
•6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
•7. Biliary obstructive disorders.
+21 more criteria

Locations (69)

Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Research Solutions, LLC

Little Rock, Arkansas, United States

Boehringer Ingelheim Investigational Site

Carmichael, California, United States

Boehringer Ingelheim Investigational Site

Concord, California, United States

Sierra Medical Research

Fresno, California, United States

Attn: Ginger Paselk

Long Beach, California, United States

Boehringer Ingelheim Investigational Site

Orange, California, United States

DeBruin Medical Center

Orangevale, California, United States

Clinical Trials Research

Roseville, California, United States

Dr. R. David Ferrera

Sacramento, California, United States

Key Dates

Start Date

July 1, 2002

Primary Completion Date

July 1, 2003

Last Updated

December 9, 2013

Enrollment

805

ACTUAL participants

Conditions

Hypertension

Interventions

Telmisartan & Hydrochlorothiazide

DRUG

Losartan & Hydrochlorothiazide

DRUG

ABPM

PROCEDURE

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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