Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg); Aliskiren (300 mg)
Intervention description: During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.; During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.
Intervention MeSH terms: Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 688.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential Hypertension; Stage II

Summary:

      This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy
      to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients
      with Stage II hypertension over a period of 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients ≥18 years of age.

          -  Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic
             Blood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.

        Exclusion Criteria:

          -  Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood
             Pressure (msDBP) ≥ 110 mmHg.

          -  Secondary form of hypertension.

          -  Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV).

          -  Current angina pectoris requiring pharmacological therapy (other than stable doses of
             oral or topical nitrates).

          -  Second or third degree heart block without a pacemaker.

          -  Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial
             fibrillation or atrial flutter, during the 12 months prior to Visit 1.

          -  Clinically significant valvular heart disease.

          -  Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack
             (TIA), heart attack, coronary bypass surgery or any PCI.

          -  Known Keith-Wagener grade III or IV hypertensive retinopathy.

          -  In the month prior to Visit 1, patients on combination antihypertensive therapy that
             includes more than 2 classes of antihypertensive medications.

          -  Patients on combined antihypertensive medication that contain two classes of
             antihypertensive medications are considered to take two antihypertensive medications.

          -  Inability to discontinue prior antihypertensive or other CV medications as required by
             the protocol.

          -  Patients with Type 1 diabetes mellitus.

          -  Patients with Type 2 diabetes mellitus not well controlled .

          -  Elevated Serum potassium (over 5.3 mEq/L (mmol/L).

          -  Any surgical or medical condition or the use of any medication which might
             significantly alter the absorption, distribution, metabolism, or excretion of study
             drugs.

        Other protocol-defined inclusion/exclusion criteria may apply.