Telmisartan 80mg Non-responder Trial

Condition(s) targeted: Hypertension

Intervention: Telmisartan and amlodipine (Drug); Telmisartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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.

Official title: An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg+ Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 80 mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg Monotherapy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough

Secondary outcome:

Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough

Seated DBP Control Rate at Trough

Seated SBP Control Rate at Trough

Seated DBP Response Rate at Trough

Seated SBP Response Rate at Trough

Seated Blood Pressure (BP) Normalisation at Trough

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

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

Starting date: October 2010
Last updated: June 17, 2014