Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Moderate to Severe Hypertension
Intervention: Aliskiren/amlodipine 300/10 mg tablet (Drug); Amlodipine 10 mg capsule (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Study Director, Affiliation: Novartis
Summary
This study will compare the blood pressure (BP) lowering effect of the combination of
aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate
to severe hypertension by testing the hypothesis that the combination of
aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic
blood pressure (msSBP) after 8 weeks of treatment.
Clinical Details
Official title: An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Sitting Systolic Blood Pressure (msSBP)
Secondary outcome: Mean Sitting Diastolic Blood Pressure (msDBP)Systolic Blood Pressure Response Diastolic Blood Pressure Response Blood Pressure Control
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Outpatients ≥ 18 years of age
- Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160
mmHg and < 200 mmHg at Visit 2
Exclusion Criteria:
- Mild to moderate hypertension
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class
II-IV.
- Serum potassium ≥ 5. 3 mEq/L (mmol/L) at Visit 1.
- Uncontrolled Type 1 or Type 2 diabetes mellitus
- Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with
Similar chemical structures
- History of hypertensive encephalopathy or cerebrovascular accident, or history of
transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or
any percutaneous coronary intervention
- Patients on a combination of 3 or more antihypertensive medications
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Investigative Site, Berlin, Germany
Investigative Site, Manilla, Philippines
Investigative Site, Bucharest, Romania
Investigative Site, Moscow, Russian Federation
Investigative Site, Singapore, Singapore
Investigative Site, Madrid, Spain
Additional Information
Starting date: January 2009
Last updated: July 5, 2011
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