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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 200 |
| Estimated Study Completion Date: | August 2005 |
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 |
Inclusion Criteria:
Essential hypertensive patients who meet all the criteria as follows:
Exclusion Criteria:
Contacts and Locations| Japan | |
| Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan, 060-0003 | |
| Boehringer Ingelheim Investigational Site | |
| Shinjuku-ku, Tokyo, Japan, 163-6003 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. |
More Information
| ClinicalTrials.gov Identifier: | NCT00144222 History of Changes |
| Other Study ID Numbers: | 502.436 |
| Study First Received: | September 2, 2005 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Hypertension Vascular Diseases Cardiovascular Diseases Telmisartan Benzoates Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Antifungal Agents Anti-Infective Agents Therapeutic Uses |
