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Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)

NCT00926289•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP\>=160 mmHg and Diastolic Blood Pressure(DBP)\>=100 mmHg).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation;
•2. Age 18 years or older;
•3. Patients with grade 2 or grade 3 hypertension as defined SBP\>=160 mmHg and DBP\>=100 mmHg at randomization
•4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's discretion)

Exclusion Criteria

•1. Pre-menopausal women (last menstruation \<=1 year prior to signing informed consent) who: a) are not surgically sterile; or b) are nursing, or c) are pregnant, or d) are of childbearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the trial. The only acceptable methods of birth control are: Intra-Uterine Device (IUD), Oral contraceptives, Implantable or injectable contraceptives, Estrogen patch Hormonal birth control should have been in use for at least three months before the study and continue at least until the next menstrual period after completing the study.
•2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
•3. Known or suspected secondary hypertension (e.g., renal artery stenosis orphaeochromocytoma)
•4. Mean in-clinic seated cuff SBP\>= 200 mmHg and/or DBP \>=120 mmHg
•5. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dL (or \>265 umol/L) and/or known creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment.
•6. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
•7. Clinically relevant hypokalemia or hyperkalemia (i.e., \<3.5 mmol/L or \>5.5 mmol/L, may be rechecked for suspected error in result)
•8. Uncorrected sodium or volume depletion
•9. Primary aldosteronism.
•10. Hereditary fructose intolerance
+13 more criteria

Locations (106)

502.550.01008 Boehringer Ingelheim Investigational Site

Athens, Alabama, United States

502.550.01019 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

502.550.01015 Boehringer Ingelheim Investigational Site

Lomita, California, United States

502.550.01003 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

502.550.01014 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

502.550.01002 Boehringer Ingelheim Investigational Site

Louisville, Kentucky, United States

502.550.01011 Boehringer Ingelheim Investigational Site

New Iberia, Louisiana, United States

502.550.01009 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

502.550.01018 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

502.550.01006 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Key Dates

Start Date

June 1, 2009

Primary Completion Date

April 1, 2010

Last Updated

June 27, 2014

Enrollment

894

ACTUAL participants

Conditions

Hypertension

Interventions

Telmisartan

DRUG

Telmisartan

DRUG

Hydrochlorothiazide

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITING

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

NCT07480265

Hypertension (HTN)Hyperhomocysteinemia+1 more

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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: June 27, 2014Data 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

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

Inclusion Criteria

Exclusion Criteria

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