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”

The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg a nd HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis?, Gliosartan?, Kinzal?, Ki nzalmono?, Predxal?, Pritor?, Samertan?, Telmisartan?) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

This is a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel-group st udy 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 ope n-label run-in period with telmisartan (Micardis?) 40 mg monotherapy to assess eligibility. The stud y will be terminated for those who have responded to telmisartan (Micardis?) 40 mg monotherapy at th e 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 monot herapy will be randomised and treated for 8 weeks with once-daily administration of either telmisart an (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 m onotherapy.

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.

Intervention(s) in this Clinical Trial

• Drug: Telmisartan 40 mg/HCTZ 12.5 mg
• Drug: Telmisartan 40 mg

Primary Measures

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

Secondary 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)

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 hypertens ion, primary aldosteronism, pheochromocytoma, etc.)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Coordinator Study Chair Nippon Boehringer Ingelheim Co., Ltd.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00144222

Study ID Number: 502.436

ClinicalTrials.gov Identifier: NCT00144222

Health Authority: Japan: Ministry of Health, Labor and Welfare