Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine 2.5 mg; Drug: Amlodipine 5 mg; Drug: Telmisartan 20 mg; Drug: Placebo; Drug: Telmisartan 40 mg; Drug: Amlodipine 10 mg; Drug: Telmisartan 80 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00281580

1235.1

2008-000874-19 (EudraCT Number)

Details and patient eligibility

About

To demonstrate that Micardis and Norvasc when used together are more effective at lowering blood pre ssure.

Enrollment: 1,461 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Main Inclusion Criteria: Male and female patients >=18 years of age with Stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=119 mmHg Main

Exclusion criteria

Exclusion Criteria:

1. Patient is pregnant; breast-feeding; unwilling to use birth control during the study; has secondary hypertension; severe renal dysfunction; hepatic insufficiency; stroke within the last six months; myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months; unstable or uncontrolled diabetes for the past three months defined as a glucosylates hemoglobin (HbA1c) greater than ten percent ; history of angioedema or hypersensitivity related to either study drug.
2. Systolic Blood Pressure (SBP) is greater than or equal to 180 millimeters of mercury (mmHg), Diastolic Blood Pressure (DBP) is greater than or equal to 110 mmHg.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,461 participants in 16 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo once daily for eight weeks

Treatment:

Drug: Placebo

Telmisartan 20 mg

Experimental group

Description:

Telmisartan 20 mg once daily for eight weeks

Treatment:

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Telmisartan 40 mg

Experimental group

Description:

Telmisartan 40 mg once daily for eight weeks

Treatment:

Drug: Telmisartan 40 mg

Drug: Telmisartan 40 mg

Drug: Telmisartan 40 mg

Drug: Telmisartan 40 mg

Telmisartan 80 mg

Experimental group

Description:

Telmisartan 80 mg once daily for eight weeks

Treatment:

Drug: Telmisartan 80 mg

Drug: Telmisartan 80 mg

Drug: Telmisartan 80 mg

Drug: Telmisartan 80 mg

Amlodipine 2.5 mg

Experimental group

Description:

Amlodipine 2.5 mg once daily for eight weeks

Treatment:

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Amlodipine 5 mg

Experimental group

Description:

Amlodipine 5 mg once daily for eight weeks

Treatment:

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Amlodipine 10 mg

Active Comparator group

Description:

Amlodipine 5 mg for two weeks and forced titrated to amlodipine 10 mg for six weeks once daily

Treatment:

Drug: Amlodipine 10 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Telmisartan 20 / Amlodipine 2.5

Experimental group

Description:

Telmisartan 20/ Amlodipine 2.5 mg once daily for eight weeks

Treatment:

Drug: Telmisartan 20 mg

Drug: Amlodipine 2.5 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Drug: Telmisartan 20 mg

Telmisartan 20 / Amlodipine 5

Experimental group

Description:

Telmisartan 20 / Amlodipine 5 mg once daily for eight weeks

Treatment:

Drug: Amlodipine 5 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 20 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Telmisartan 20 / Amlodipine 10

Experimental group

Description:

Telmisartan 20 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Treatment:

Drug: Amlodipine 10 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Telmisartan 20 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 10 mg

Drug: Telmisartan 20 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Telmisartan 40 / Amlodipine 2.5

Experimental group

Description:

Telmisartan 40 / Amlodipine 2.5 for eight weeks

Treatment:

Drug: Telmisartan 40 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Drug: Telmisartan 40 mg

Drug: Telmisartan 40 mg

Drug: Amlodipine 2.5 mg

Drug: Telmisartan 40 mg

Telmisartan 40 / Amlodipine 5

Experimental group

Description:

Telmisartan 40 / Amlodipine 5 for eight weeks

Treatment:

Drug: Telmisartan 40 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 40 mg

Drug: Telmisartan 40 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 40 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Telmisartan 40 / Amlodipine 10

Experimental group

Description:

Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Treatment:

Drug: Amlodipine 10 mg

Drug: Telmisartan 40 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 40 mg

Drug: Telmisartan 40 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 10 mg

Drug: Telmisartan 40 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Telmisartan 80 / Amlodipine 2.5

Experimental group

Description:

Telmisartan 80 / Amlodipine 2.5 for eight weeks

Treatment:

Drug: Telmisartan 80 mg

Drug: Amlodipine 2.5 mg

Drug: Telmisartan 80 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 2.5 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 2.5 mg

Drug: Amlodipine 2.5 mg

Telmisartan 80 / Amlodipine 5

Experimental group

Description:

Telmisartan 80 / Amlodipine 5 mg for eight weeks

Treatment:

Drug: Amlodipine 5 mg

Drug: Telmisartan 80 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Telmisartan 80 / Amlodipine 10

Experimental group

Description:

Telmisartan 40 / Amlodipine 5 for two weeks and forced titrated to amlodipine 10 mg for six weeks

Treatment:

Drug: Amlodipine 10 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 80 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 5 mg

Drug: Telmisartan 80 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 10 mg

Drug: Amlodipine 5 mg

Drug: Amlodipine 5 mg