- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01286558
Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Chuo-ku,Tokyo, Japan
- 1235.37.01 Boehringer Ingelheim Investigational Site
-
Hiroshima, Hiroshima, Japan
- 1235.37.07 Boehringer Ingelheim Investigational Site
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Itoshima, Fukuoka, Japan
- 1235.37.08 Boehringer Ingelheim Investigational Site
-
Katsushika-ku, Tokyo, Japan
- 1235.37.02 Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Japan
- 1235.37.05 Boehringer Ingelheim Investigational Site
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Ota-ku, Tokyo, Japan
- 1235.37.03 Boehringer Ingelheim Investigational Site
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Suita, Osaka, Japan
- 1235.37.06 Boehringer Ingelheim Investigational Site
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Yokohama, Kanagawa, Japan
- 1235.37.04 Boehringer Ingelheim Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Essential hypertensive patients
- If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be >=90 and >=114 mmHg
- If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114 mmHg
- Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.
Exclusion criteria:
- Patients taking 3 or more antihypertensive drugs at signing the informed consent form
- Patients with known or suspected secondary hypertension
- Patients with clinically relevant cardiac arrhythmia
- Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
- Patients with recent cardiovascular events
- Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
- Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
- Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
- Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
- Patients with hepatic and/or renal dysfunction
- Pre-menopausal women who are nursing or pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 80mg telmisartan and 5mg amlodipine FDC
once daily
|
once daily
once daily
|
Active Comparator: 40mg telmisartan and 5mg amlodipine FDC
once daily
|
once daily
once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
Time Frame: 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
|
Reference baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Seated DBP Control Rate at Trough
Time Frame: 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
|
8 weeks
|
Seated Blood Pressure (BP) Normalisation at Trough
Time Frame: 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
|
8 weeks
|
Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
Time Frame: 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
|
Reference baseline, 8 weeks
|
Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP
Time Frame: 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
|
Reference baseline, 8 weeks
|
Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Time Frame: 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
|
Reference baseline, 8 weeks
|
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP
Time Frame: 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
|
Pseudo-baseline, 14 weeks
|
Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Time Frame: 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
|
Pseudo-baseline, 14 weeks
|
Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Time Frame: 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
|
Reference baseline, 8 weeks
|
Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Time Frame: 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
|
Reference baseline, 8 weeks
|
Seated SBP Control Rate at Trough
Time Frame: 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
|
8 weeks
|
Seated DBP Response Rate at Trough
Time Frame: 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
|
8 weeks
|
Seated SBP Response Rate at Trough
Time Frame: 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
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Telmisartan
Other Study ID Numbers
- 1235.37
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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