Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
- Conditions
- Hypertension
- Interventions
- Drug: 5 mg amlodipineDrug: 40 mg telmisartanDrug: 80 mg telmisartan
- Registration Number
- NCT01286558
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.
In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.
Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 80mg telmisartan and 5mg amlodipine FDC 5 mg amlodipine once daily 40mg telmisartan and 5mg amlodipine FDC 40 mg telmisartan once daily 80mg telmisartan and 5mg amlodipine FDC 80 mg telmisartan once daily 40mg telmisartan and 5mg amlodipine FDC 5 mg amlodipine once daily
- Primary Outcome Measures
Name Time Method Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough Reference baseline, 8 weeks Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
- Secondary Outcome Measures
Name Time Method Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP Reference baseline, 8 weeks Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP Reference baseline, 8 weeks Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
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 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
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Reference baseline, 8 weeks Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
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
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
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP Pseudo-baseline, 14 weeks Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP Pseudo-baseline, 14 weeks Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM Reference baseline, 8 weeks Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Seated SBP Control Rate at Trough 8 weeks SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 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 Reference baseline, 8 weeks Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Trial Locations
- Locations (8)
1235.37.08 Boehringer Ingelheim Investigational Site
🇯🇵Itoshima, Fukuoka, Japan
1235.37.01 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku,Tokyo, Japan
1235.37.05 Boehringer Ingelheim Investigational Site
🇯🇵Osaka, Osaka, Japan
1235.37.06 Boehringer Ingelheim Investigational Site
🇯🇵Suita, Osaka, Japan
1235.37.04 Boehringer Ingelheim Investigational Site
🇯🇵Yokohama, Kanagawa, Japan
1235.37.03 Boehringer Ingelheim Investigational Site
🇯🇵Ota-ku, Tokyo, Japan
1235.37.07 Boehringer Ingelheim Investigational Site
🇯🇵Hiroshima, Hiroshima, Japan
1235.37.02 Boehringer Ingelheim Investigational Site
🇯🇵Katsushika-ku, Tokyo, Japan