Telmisartan 80mg Non-responder Trial

NCT ID: NCT01222520

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31

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.

Conditions

Hypertension

Study Design

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

Study Groups

Telmisartan and amlodipine FDC

once a daily

Group Type: EXPERIMENTAL

Telmisartan and amlodipine

Intervention Type: DRUG

Telmisartan 80 mg and amlodipine 5 mg once a daily

Telmisartan monotherapy

once a daily

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

80 mg once a daily

Interventions

Telmisartan and amlodipine

Telmisartan 80 mg and amlodipine 5 mg once a daily

Intervention Type: DRUG

Telmisartan

80 mg once a daily

Intervention Type: DRUG

Eligibility Criteria

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

• 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

1235.36.01 Boehringer Ingelheim Investigational Site

Chuo-ku,Tokyo, , Japan

1235.36.04 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, , Japan

1235.36.02 Boehringer Ingelheim Investigational Site

Shinjuku-ku, Tokyo, , Japan

1235.36.03 Boehringer Ingelheim Investigational Site

Suita, Osaka, , Japan

Countries

Japan

Other Identifiers

1235.36

Identifier Type: -

Identifier Source: org_study_id