Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

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.

Intervention(s) in this Clinical Trial

• Drug: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
  • During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
• Drug: Aliskiren (300 mg)
  • During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)
  • Time Frame: Baseline to end of study (Week 12)
    Safety Issue?: No

Secondary Measures

• Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
  • Time Frame: Baseline to Week 8
    Safety Issue?: No
• Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

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.

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 Investigator: Novartis Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

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