Telmisartan 80mg Non-responder Trial

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Telmisartan and amlodipine

• Registration Number: NCT01222520
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly.

In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg.

Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2011-06
• Results First Submitted: 2012-05-31
• Results First Submitted QC: 2012-05-31
• Results First Posted: 2012-07-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan monotherapy	Telmisartan	once a daily
Telmisartan and amlodipine FDC	Telmisartan and amlodipine	once a daily

Primary Outcome Measures

Name	Time	Method
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough	Baseline, 8 weeks	Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

Secondary Outcome Measures

Name	Time	Method
Seated DBP Response Rate at Trough	8 weeks	DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (\<90 mmHg and/or reduction from reference baseline ≥10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough	Baseline, 8 weeks	Reference baseline: Status of patients after the 8-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Seated DBP Control Rate at Trough	8 weeks	DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Seated SBP Control Rate at Trough	8 weeks	SBP control rate: The rate of patients with controlled seated SBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Seated SBP Response Rate at Trough	8 weeks	SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (\<140 mmHg and/or reduction from reference baseline ≥20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Seated Blood Pressure (BP) Normalisation at Trough	8 weeks	Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing

Trial Locations

Locations (4)

1235.36.04 Boehringer Ingelheim Investigational Site; 🇯🇵 Hiroshima, Hiroshima, Japan

1235.36.02 Boehringer Ingelheim Investigational Site; 🇯🇵 Shinjuku-ku, Tokyo, Japan

1235.36.01 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Tokyo, Japan

1235.36.03 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan