Non-responder Study to Telmisartan 40 mg - Tabular View

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

September 29, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Primary Endpoint: The primary endpoint is the change from baseline in mean stated trough DBT

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00144222 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in seated trough SBP at the end of 8-week double-blind treatment Seated DBP control rate (seated trough DBP < 90 mmHg at the end of 8-week double-blind treatment)

Original Secondary Outcome Measures ^ICMJE

-Change from baseline in seated trough SBP at the end of 8-week double-blind treatment -Seated DBP control rate (seated trough DBP < 90 mmHg at the end of 8-week double-blind treatment)

Descriptive Information

Brief Title ^ICMJE

Non-responder Study to Telmisartan 40 mg

Official Title ^ICMJE

A Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Telmisartan 40 mg/HCTZ 12.5 mg
Drug: Telmisartan 40 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

200

Completion Date

August 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.)

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00144222

Responsible Party

Study ID Numbers ^ICMJE

502.436

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim Study Coordinator

Nippon Boehringer Ingelheim Co., Ltd.

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP