Telmisartan 80mg Non-responder Trial

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Telmisartan and amlodipine

Drug: Telmisartan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01222520

1235.36

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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