Non-Responder Study to Telmisartan 40 mg - Full Text View

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00144222

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Telmisartan 40 mg/HCTZ 12.5 mg Drug: Telmisartan 40 mg	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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)

Estimated Enrollment:	200
Estimated Study Completion Date:	August 2005

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.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144222

Locations

Japan
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 060-0003
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 163-6003

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim Study Coordinator

Nippon Boehringer Ingelheim Co., Ltd.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	502.436
Study First Received:	September 2, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00144222 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Benzoates
Antifungal Agents
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors

Telmisartan
Angiotensin II
Hydrochlorothiazide
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Benzoates
Vascular Diseases
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

Angiotensin II Type 1 Receptor Blockers
Antifungal Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on July 02, 2009