Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

NCT ID: NCT01286558

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

80mg telmisartan and 5mg amlodipine FDC

once daily

Group Type: EXPERIMENTAL

5 mg amlodipine

Intervention Type: DRUG

once daily

80 mg telmisartan

Intervention Type: DRUG

once daily

40mg telmisartan and 5mg amlodipine FDC

once daily

Group Type: ACTIVE_COMPARATOR

40 mg telmisartan

Intervention Type: DRUG

once daily

5 mg amlodipine

Intervention Type: DRUG

once daily

Interventions

40 mg telmisartan

once daily

Intervention Type: DRUG

5 mg amlodipine

once daily

Intervention Type: DRUG

5 mg amlodipine

once daily

Intervention Type: DRUG

80 mg telmisartan

once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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

2. Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion Criteria

1. Patients taking 3 or more antihypertensive drugs at signing the informed consent form

2. Patients with known or suspected secondary hypertension

3. Patients with clinically relevant cardiac arrhythmia

4. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV

5. Patients with recent cardiovascular events

6. Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form

7. 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

8. 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

9. Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs

10. Patients with hepatic and/or renal dysfunction

11. Pre-menopausal women who are nursing or pregnant

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1235.37.01 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, , Japan

1235.37.07 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, , Japan

1235.37.08 Boehringer Ingelheim Investigational Site

Itoshima, Fukuoka, , Japan

1235.37.02 Boehringer Ingelheim Investigational Site

Katsushika-ku, Tokyo, , Japan

1235.37.05 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1235.37.03 Boehringer Ingelheim Investigational Site

Ota-ku, Tokyo, , Japan

1235.37.06 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

1235.37.04 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Countries

Japan

Other Identifiers

1235.37

Identifier Type: -

Identifier Source: org_study_id