A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension

This study has been completed.

First Received: August 22, 2005 Last Updated: March 2, 2009 History of Changes

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00133185

Purpose

The primary objective of this trial is to compare the efficacy and safety of telmisartan 40 mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide 12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate hypertension.

Condition	Intervention	Phase
Hypertension	Drug: telmisartan 40 mg/hydrochlorothiazide 12.5 mg Drug: losartan 50 mg/hydrochlorothiazide 12.5 mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Parallel-Group Assessment of the Safety and Efficacy of Telmisartan 40 mg + HCTZ 12.5 mg in Comparison With Losartan 50mg + HCTZ 12.5 mg in Taiwanese Patients With Mild to Moderate Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Change from baseline in sitting diastolic blood pressure (DBP) at trough (24 hours post-dosing) at the last observation during the double-blind phase. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

Change from baseline in sitting SBP, standing DBP, standing SBP, sitting and standing heart rate at trough as well as blood pressure control and blood pressure response as defined in study protocol at the last observation will be evaluated. [ Time Frame: 8 weeks ]

Estimated Enrollment:	40
Study Start Date:	March 2004
Estimated Study Completion Date:	January 2005

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mild to moderate hypertension as defined by a morning mean(>95 and <115mmHg) of two diastolic blood pressure measurements (DBP) after 5 min in the sitting position following a minimum 2-week placebo run in phase.Mean sitting systolic blood pressure (SBP) must be >140 and <200mmHg. The mean DBP and SBP values are calculated as the mean of the two sitting measurements taken 2 min apart just before the drug intake.
Male or female between 20 to 80 years old
Ability to provide written informed consent.

Exclusion Criteria:

Patients are still taking more than three anti-hypertensives at the screening visit
Pre-menopausal women
Known or suspected secondary hypertension
Mean sitting DBP<95mmHg and/or mean sitting SBP > 200mmHg at the end of placebo run-in phase
Hepatic and/or renal dysfunction
Known bilateral renal artery stenosis, patient with a solitary kidney, post renal transplant
Known NYHA functional class Chronic Heart Failure (CHF) III, IV
Unstable angina, myocardial infarction, cardiac surgery or stroke within the preceding six months
Post-Transluminal Coronary Angioplasty(PTCA) within the preceding three months
Sustained ventricular tachycardia, atria fibrillation, second or third degree AV block, VPC or APC (>10% of heart rate) or other clinically relevant cardiac arrhythmia as determined by the clinical investigator
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve.
Once documented evidence by ophthalmological examination of significant retinal haemorrhages/ exudates
Clinically significant sodium depletion as defined by serum sodium level less than 130 mmol/L
Clinically significant hyperkalemia as defined by serum potassium level >5.5 mmol/L
Non-insulin dependent DM poorly controlled whicih is defined as HbA1c>8% twice consecutively within 6 months and/or AC blood sugar>180 mg/dl.
Insulin Dependent Diabetes Mellitus
Chronic administration of oral anticoagulants and/or digoxin within the past 6 months.
Known drug or alcohol dependency
Administration of medication known to affect blood pressure, except medication allowed by the protocol
Angioedema with ACE inhibitors
Use of nitrates

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133185

Locations

Taiwan
Machay Memorial Hospital
Taipei, Taiwan, 104

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

B.I. Taiwan Ltd.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	502.406
Study First Received:	August 22, 2005
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00133185 History of Changes
Health Authority:	Taiwan: Department of Health

Additional relevant MeSH terms:

Anti-Infective Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Benzoates
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Anti-Arrhythmia Agents
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on November 20, 2009