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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00144222
• Lead Sponsor: Boehringer Ingelheim

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, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy.

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) 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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in mean seated trough DBP after eight weeks of the double-blind treatment period	after 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in seated trough SBP	after 8 weeks
Seated DBP control rate (seated trough DBP < 90 mmHg)	after 8 weeks
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
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
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
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
Change in trough pulse pressure	after 8 weeks
Plasma concentrations of Telmisartan and HCTZ	Day 56

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan