Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hypertension
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
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, Kinza...
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)...
Eligibility Criteria
Inclusion
- 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
- Patients taking 4 or more anti-hypertensive medications at Visit 1
- Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT00144222
Start Date
January 1 2005
End Date
August 1 2005
Last Update
November 5 2013
Active Locations (2)
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1
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 060-0003
2
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 163-6003