Official Title: “A 12 Week, Double-Blind, Randomized, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Aliskiren / HCTZ (300/25 mg)
  • aliskiren/HCTZ 300/25 m
• Drug: Aliskiren
  • Aliskiren 300 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Aliskiren/HCTZ
  • aliskiren / hydrochlorothiazide (HCTZ) (300/25 mg)
• Active Comparator: Aliskiren
  • aliskiren 300 mg

Primary Measures

• Change from baseline in mean sitting systolic blood pressure (msSBP) after 12-weeks of treatment.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in msSBP (after 8 weeks of treatment) and in msDBP ( after 12 and 8 weeks of treatment)for aliskiren / HCTZ (300/25 mg) combination vs. aliskiren (300 mg) monotherapy
  • Time Frame: 8 and 12 weeks
    Safety Issue?: No
• Change from baseline in msSBP and msDBP after 12 and 8 weeks of treatment with aliskiren / HCTZ (300/25 mg) combination
  • Time Frame: 8 and 12 weeks
    Safety Issue?: No
• Change from baseline in msSBP and msDBP after 12 and 8 weeks of aliskiren (300 mg) monotherapy.
  • Time Frame: 8 and 12 weeks
    Safety Issue?: No
• Proportion of patients achieving the target blood pressure (msSBP < 140 mmHg and msDBP < 90 mmHg, and msSBP < 130 mmHg and msDBP < 80 mmHg for diabetics), in both study arms, after 12 and 8 weeks of treatment.
  • Time Frame: 8 and 12 weeks
    Safety Issue?: No
• Safety and tolerability of aliskiren / HCTZ (300/25 mg) combination compared to aliskiren (300 mg) monotherapy regimen in patients with Stage II hypertension.
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Outpatients ≥18 years of age.
• Patients with a diagnosis of Stage II hypertension, defined as msSBP ≥ 160 mmHg and <
• 180 mmHg at Visit 2.

Exclusion Criteria:

• Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg.
• Secondary form of hypertension.
• Current diagnosis of heart failure (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, 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00705575

Study ID Number: CSPP100A2353

ClinicalTrials.gov Identifier: NCT00705575

Health Authority: United States: Food and Drug Administration