Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren (Drug); Ramipril (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
Overall contact:
Novartis, Phone: +41 61 324 1111
Summary
This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300
mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.
Clinical Details
Official title: An Eight Week, Double-Blind, Randomized, Multicenter, Parallel Group, Active-Controlled Study Comparing the Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg to Ramipril 5 mg in Patients With Essential Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate whether aliskiren 300 mg has non-inferior efficacy compared to ramipril 5 mg on reduction in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint in patients with essential hypertension.
Secondary outcome: To evaluate whether aliskiren 300 mg and aliskiren 150 mg have superior efficacy compared to ramipril 5 mg on systolic and diastolic BP, if the non-inferiorities in primary objectives are achieved.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to
Visit 3
- Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
- Patients must have an absolute difference of < or =10 mmHg in their mean sitting
diastolic blood pressure (msDBP) from Visit 2 to Visit 3
Exclusion Criteria:
- Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or
= 180 mmHg).
- History or evidence of a secondary form of hypertension.
- History of transient ischemic cerebral attack within 12 months of visit 1.
- Current angina pectoris requiring pharmacological therapy (other than those patients
on a stable dose of oral or topical nitrates)
- Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit
1.
- Known or suspected contraindications to the study medications, including history of
allergy to ramipril or other ACE Inhibitors.
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis, Phone: +41 61 324 1111
Novartis Investigative Sites, China, China; Recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigative Sites, India, India; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Novartis Investigative Sites, Thailand, Thailand; Not yet recruiting
Novartis, Phone: +41 61 324 1111
Additional Information
Starting date: September 2007
Last updated: January 9, 2008
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