Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome
Condition: Hypertension With Metabolic Syndrome
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Intervention: Amlodipine; Aliskiren; Ramipril
Intervention description: amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.; aliskiren 150-300 mg tablets. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.; ramipril 5-10 mg capsules. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
Intervention MeSH terms: Amlodipine; Ramipril
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypertension; Metabolic Syndrome; Dual combination therapy; Triple combination therapy; Aliskiren; Direct Renin inhibitor

Summary:

      This proof of concept study is designed to evaluate the efficacy and safety of the
      combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of
      patients with essential hypertension and metabolic syndrome who do not respond adequately to
      amlodipine monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients 18-75 years of age.

          -  Male or female patients are eligible.

          -  Patients with a diagnosis of hypertension:

          -  Newly diagnosed patients or patients who have not been treated for hypertension within
             the 4 weeks prior to Visit 1 must have a mean sitting systolic blood pressure (MSSBP)
             > 150 mmHg and < 180 mmHg at Visit 1.

          -  Patients treated with antihypertensive monotherapy must have a MSSBP ≥ 140 mmHg and
             <180 mmHg at Visit 1.

          -  Patients taking amlodipine monotherapy MSSBP > 140 mmHg and < 180 mmHg at visit 1.

          -  All patients must have a MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 3, the end of the
             amlodipine run-in period.

          -  Metabolic syndrome.

          -  Patients who are eligible and able to participate in the study, and who consent to do
             so after the purpose and nature of the investigation has been clearly explained to
             them (written inform consent form).

        Exclusion Criteria:

          -  Severe hypertension (office cuff MSDBP ≥ 115 mmHg and/or MSSBP ≥ 180 mmHg).

          -  History or evidence of a secondary form of hypertension.

          -  History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic
             cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any
             percutaneous coronary intervention (PCI).

          -  Serum sodium < 135 mmol/L at Visit 1 if confirmed on repeat sample.

          -  Serum potassium < 3.5 mmol/L or ≥ 5.3 mmol/L at Visit 1, if confirmed on repeat
             sample.

          -  Type 1 diabetes mellitus.

          -  Type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication
             change) in previous 3 months.

          -  Pregnant or nursing (lactating) women.

        Other protocol-defined inclusion/exclusion criteria applied to the study.