Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
Condition: Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Diabetes Mellitus; Systolic Murmurs
Intervention: Aliskiren; Valsartan; Placebo for Aliskiren; Placebo for Valsartan
Intervention description: Aliskiren 150 mg tablet; Valsartan 160 mg capsules; Placebo for Aliskiren 150 mg tablets; Placebo for Valsartan 160 mg capsules
Intervention MeSH terms: Valsartan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, Type II Diabetes, Aliskiren, Valsartan,; Systolic blood pressure, Diastolic blood pressure,; Stage II, Combination

Summary:

      The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the
      combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy
      in Type II Diabetic patients with Stage II hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are eligible and able to participate in the study, and who give written
             informed consent before any assessment is performed.

          -  Men or women 18 years and older.

          -  Patients with Type 2 diabetes mellitus with an HbA1c ≤ 9 % at visit 1 and on a stable
             anti-diabetic regimen not including insulin or stable diet and exercise for at least 4
             weeks prior to visit 1.

        Cohort 1:

          -  Patients with Stage 2 systolic hypertension, defined as having a MSSBP ≥160 mmHg and
             <200 mmHg at Visit 5 (randomization).

          -  Patients who have been newly diagnosed with hypertension or who have not received
             antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have
             MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 1, otherwise, they will be considered screen
             failures.

          -  Patients receiving antihypertensive medication must have a MSSBP of ≥150 mmHg and <200
             mmHg at Study Visit 1, otherwise they will be considered screen failures.

        Cohort 2:

          -  Patients must also have had a mean 8-hour daytime ambulatory systolic blood pressure
             (ASBP) ≥140 mmHg AND mean 8-hour daytime ambulatory diastolic blood pressure (ADBP)
             ≥90 mmHg at Visit 5 (randomization).

          -  Hypertensive patients with MSSBP ≥150 mmHg and but <200 mmHg AND MSDBP ≥95 but <120
             mmHg at Visit 5 (randomization).

          -  Patients who had been newly diagnosed with hypertension or who had not received
             antihypertensive medication for at least 4 weeks (28 days) prior to Visit 1 must have
             had MSSBP ≥150 mmHg but <200 mmHg and MSDBP ≥95 but <120 mmHg at Visit 1, otherwise,
             they were considered screen failures.

        Exclusion Criteria:

          -  Office blood pressure measured by cuff (MSSBP ≥200 mmHg or MSDBP ≥120 mmHg).

          -  History or evidence of secondary hypertension of any etiology.

          -  Refractory hypertension, defined as having uncontrolled BP (≥140/90 mmHg) while
             receiving 3 antihypertensive medications at the maximum approved dose of each drug,
             one of which must be a diuretic.

          -  Patients treated with more than 3 antihypertensive medications (each component of a
             combination drug counts individually).

          -  Type 2 diabetes mellitus currently requiring insulin treatment.

          -  modification of diet in renal disease (MDRD) estimated glomerular filtration rate
             (eGFR) < 60 mL/min/1.73m2

          -  Serum sodium less than lower limit of normal, serum potassium < 3.5 mEq/L or ≥ 5.3
             mEq/L at Visit 1.

          -  Known Keith-Wagener grade III or IV hypertensive retinopathy.

        Cohort 1:

        - Patients with known diabetic retinopathy (eg, having a history of laser therapy for
        diabetic retinopathy) or diabetic neuropathy (eg, receiving medication for diabetic
        neuropathy).

        Cohort 2:

        - Patients with known diabetic retinopathy or diabetic neuropathy and/or having a history
        of treatment for either.

        Other protocol-defined inclusion/exclusion criteria applied.