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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144222
• Other study ID #: 502.436
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: November 4, 2013
• Start date: January 2005
• Est. completion date: August 2005

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan 40 mg/HCTZ 12.5 mg

• Telmisartan 40 mg

Locations

Country	Name	City	State
Japan	Boehringer Ingelheim Investigational Site	Sapporo, Hokkaido
Japan	Boehringer Ingelheim Investigational Site	Shinjuku-ku, Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean seated trough DBP after eight weeks of the double-blind treatment period		after 8 weeks	No
Secondary	Change in seated trough SBP		after 8 weeks	No
Secondary	Seated DBP control rate (seated trough DBP < 90 mmHg)		after 8 weeks	No
Secondary	Seated DBP response rate V2 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP = 10 mmHg)		after 8 weeks	No
Secondary	Seated DBP response rate V3 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP = 10 mmHg)		after 8 weeks	No
Secondary	Seated SBP response rate V2 (seated trough SBP < 140 mmHg and/or reduction from pseudo-baseline in seated trough SBP = 10 mmHg)		after 8 weeks	No
Secondary	Seated SBP response rate V3 (seated trough SBP = 140 mmHg at baseline and seated trough SBP < 140 mmHg and/or reduction from baseline in seated trough SBP = 10 mmHg)		after 8 weeks	No
Secondary	Change in trough pulse pressure		after 8 weeks	No
Secondary	Plasma concentrations of Telmisartan and HCTZ		Day 56	No

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