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  Drug: Telmisartan 40 mg/HCTZ 12.5 mg	Phase III

Further Study Details: 

Primary Outcomes: Primary Endpoint: The primary endpoint is the change from baseline in mean stated trough DBT
Secondary Outcomes: -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)
Expected Total Enrollment:  200

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®) 40mg 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 patient 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 8-week double-blind treatment will be expressed.

Ages Eligible for Study:  30 Years   -   70 Years,  Genders Eligible for Study:  Both

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.)

Japan
      Tomita Medical Clinic, Sapporo, Hokkaido,  060-0003,  Japan
      Shinjuku Oak Tower Clinic, Shinjuku-ku, Tokyo,  163-6003,  Japan

Study chairs or principal investigators

Masashi Uchida,  Study Chair,  Nippon Boehringer/Kawanishi   

Study ID Numbers:  502.436
Last Updated:  September 9, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144222
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13