MedDataX Logo

Combination of Telmisartan 40 mg Plus Hydrochlorothiazide (HCTZ) 12.5 mg vs. Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan Monotherapy

NCT ID: NCT00144222

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel-group study in patients with essential hypertension who fail to respond adequately to telmisartan (Micardis) 40 mg monotherapy.

After a screening and a 2-week washout period (screening period), the patients will enter 4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy to assess eligibility. The study will be terminated for those who have responded to telmisartan (Micardis) 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy (mean seated DBP \< 90 mmHg). About 200 patients not responding adequately to telmisartan (Micardis) 40 mg monotherapy will be randomised and treated for 8 weeks with once-daily administration of either telmisartan (Micardis) 40 mg or a fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg (double-blind treatment period).

Study Hypothesis:

The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis) 40 mg in pat ient with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Comparison(s):

For the primary comparison the change from baseline in mean stated trough DBP at the end of the 8-week double-blind treatment will be expressed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Telmisartan 40 mg/HCTZ 12.5 mg

Intervention Type DRUG

Telmisartan 40 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Essential hypertensive patients who meet all the criteria as follows:

* Mean seated DBP must be \>= 95 and \<= 114 mmHg at Visit 2
* Mean seated SBP must be \>= 140 and \<= 200 mmHg at Visit 2
* Mean seated DBP must be \>= 90 and \<= 114 mmHg at Visit 3
* Mean seated SBP must be \<= 200 mmHg at Visit 3

Exclusion Criteria

* Patients taking 4 or more anti-hypertensive medications at Visit 1
* Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Nippon Boehringer Ingelheim Co., Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

Site Status

Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

502.436

Identifier Type: -

Identifier Source: org_study_id