Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine 5 mg; Placebo; Telmisartan 20 mg; Telmisartan 40 mg; Amlodipine 10 mg; Telmisartan 20 mg; Telmisartan 80 mg; Amlodipine 10 mg; Telmisartan 20 mg; Amlodipine 5 mg; Amlodipine 5 mg; Telmisartan 20 mg; Amlodipine 5 mg; Amlodipine 5 mg; Amlodipine 2.5 mg; Amlodipine 2.5 mg; Amlodipine 10 mg; Amlodipine 2.5 mg; Telmisartan 80 mg; Telmisartan 80 mg; Amlodipine 5 mg; Amlodipine 2.5 mg; Telmisartan 40 mg; Telmisartan 40 mg; Amlodipine 5 mg; Amlodipine 5 mg; Telmisartan 40 mg; Telmisartan 80 mg; Amlodipine 10 mg
Intervention description: Amlodipine 5 mg once daily for two weeks; Placebo to Telmisartan and Amlodipine once daily for eight weeks; Telmisartan 20 mg once daily for eight weeks; Telmisartan 40 mg once daily for eight weeks; Amlodipine 10 mg once daily for six weeks; Telmisartan 20 mg once daily for eight weeks; Telmisartan 80 mg once daily for eight weeks; Amlodipine 10 mg once daily for six weeks; Telmisartan 20 mg once daily for eight weeks; Amlodipine 5 mg once daily for two weeks; amlodipine 5g once daily for eight weeks; Telmisartan 20 mg once daily for eight weeks; Amlodipine 5 mg once daily for eight weeks; amlodipine 5mg once daily for eight weeks; Amlodipine 2.5 mg once daily for eight weeks; Amlodipine 2.5 mg once daily for eight weeks; Amlodipine 10 mg once daily for six weeks; Amlodipine 2.5 mg once daily for eight weeks; Telmisartan 80 mg once daily for eight weeks; Telmisartan 80 mg once daily for eight weeks; Amlodipine 5 mg once daily for two weeks; Amlodipine 2.5 mg once daily for eight weeks; Telmisartan 40 mg once daily for eight weeks; Telmisartan 40 mg once daily for eight weeks; amlodipine 5g once daily for two weeks; Amlodipine 5 mg once daily for eight weeks; Telmisartan 40 mg once daily for eight weeks; Telmisartan 80 mg once daily for eight weeks; Amlodipine 10 mg once daily for six weeks
Intervention MeSH terms: Amlodipine; Telmisartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Enrollment: 1461.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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.