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

November 18, 2013 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

Study Type

Interventional

Enrollment

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

Taiwan
- - Taipei, Taiwan, 104
    - Machay Memorial Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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	8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

Study Chair: Boehringer Ingelheim Study Coordinator, B.I. Taiwan Ltd.

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

Related Info

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

March 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Completion