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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg) (Drug); Aliskiren (300 mg) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)

Secondary outcome:

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Investigative Site, Buenos Aires, Argentina

Investigative Site, Quito, Ecuador

Investigative Site, Berlin, Germany

Investigative Site, Guatemala City, Guatemala

Investigative Site, Rome, Italy

Investigative Site, Basel, Switzerland

Investigative Site, Ankara, Turkey

Investigative Site, East Hanover, New Jersey 07936, United States

Additional Information

Starting date: June 2008
Last updated: May 24, 2011

Page last updated: August 23, 2015

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