Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension

October 20, 2014 updated by: Boehringer Ingelheim

12 Week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Group Trial Comparing the Efficacy and Safety of 40 & 80 mg Telmisartan and 50 & 100 mg Losartan in the Treatment of 150 Pairs of Primary Hypertension Patients

Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 3

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and < 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) < 180 mmHg

Exclusion Criteria:

- Not specified

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan
Low dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered
Drug: Low dose of telmisartan
Drug: High dose of telmisartan
Active Comparator: Losartan
Low dose of losartan, uptitrated to high dose in case no sufficient effect is observered
Drug: Low dose of losartan
Drug: High dose of losartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mean sitting valley value of DBP
Time Frame: 8 weeks after start of treatment
The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives
8 weeks after start of treatment

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, 2000

Primary Completion (Actual)

January 1, 2001

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

October 21, 2014

Last Update Submitted That Met QC Criteria

October 20, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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