Add-on to Micamlo BP Trial

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: hydrochlorothiazide; Drug: Telmisartan + amlodipine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01975246

1348.1

Details and patient eligibility

About

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Enrollment: 309 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Essential hypertensive patients who have already taking 2 or 3 antihypertensive drugs and mean seated diastolic blood pressure (DBP) must be >=90 and <=114 mmHg and mean seated systolic blood pressure (SBP) must be =<200 mmHg
• Able to stop all current antihypertensive drugs (other than study medication) from Visit 1b through the end of the trial without risk to the patient based on the investigator's opinion
• Age 20 years or older

Exclusion criteria

• 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 recent stroke events
• Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers or angiotensin converting enzyme inhibitors; or patients with post-renal transplant or post-nephrectomy
• Patients with hepatic and/or renal dysfunction
• Pre-menopausal women who are nursing or pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 2 patient groups

Telmisartan+amlodipine+HCTZ

Experimental group

Description:

telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet

Treatment:

Drug: hydrochlorothiazide

Drug: Telmisartan + amlodipine

Drug: Telmisartan + amlodipine

Telmisartan+amlodipine

Active Comparator group

Description:

telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet

Treatment:

Drug: Placebo

Drug: Telmisartan + amlodipine

Drug: Telmisartan + amlodipine