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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Hydrochlorothiazide

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.