Status:
COMPLETED
Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT00705575
Start Date
June 1 2008
End Date
April 1 2009
Last Update
May 30 2011
Active Locations (8)
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1
Investigative Site
East Hanover, New Jersey, United States, 07936
2
Investigative Site
Buenos Aires, Argentina
3
Investigative Site
Quito, Ecuador
4
Investigative Site
Berlin, Germany