Overview

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

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Boehringer Ingelheim
Treatments:
Hydrochlorothiazide
Telmisartan
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.)