Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-Severe Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Moderate-Severe Hypertension
Intervention: Aliskiren 150/Amlodipine 5 mg, 300/10 mg (Drug); Aliskiren 150/Hydrochlorothiazide 12.5 mg, 300/25 mg (Drug); Amlodipine 150/Hydrochlorothiazide 12.5 mg, 10/25 mg (Drug); Aliskiren 150/Amlodipine 5/Hydrochlorothiazide 12.5 mg, 300/10/25 mg (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Novartis Overall contact:
Novartis, Phone: 862-778-8300
Summary
Evaluate the efficacy (blood pressure lowering effect) and safety of
Aliskiren/Amlodipine/Hydrochlorothiazide in patients with moderate to severe Hypertension.
Clinical Details
Official title: An 8 Week, Double-Blind, Randomized, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren /Amlodipine / HCTZ in Patients With Moderate to Severe Hypertension
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Vital signs at every visit
Secondary outcome: Vital signs at every visitAdverse events at every visit 24-hour ambulatory blood pressure measurement of a subset of patients at Day 1 and Day 56 (end of study) Changes in biomarker assessments (PRA, PRC) at Day 1 and Day 56 in subset of patients Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female
- 18 years of age or older
- Diagnosis of moderate to severe hypertension
Exclusion Criteria:
- Continued use of anti-hypertensive medicines or use of 4 or more hypertensive
medicines at study start
- Extremely elevated (defined) blood pressure at any point during the study
- Pregnant or lactating women
- Pre-menopausal women not taking accepted form of birth control
- History or evidence of secondary form of hypertension
- History of cardiovascular conditions
Other protocol-defined inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis, Phone: 862-778-8300
Investigative Site, Sydney, Australia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Ottawa, Canada; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Copenhagen, Denmark; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Berlin, Germany; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Jerusalem, Israel; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Rome, Italy; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Riga, Latvia; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Vilnius, Lithuania; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Bucharest, Romania; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Pretoria, South Africa; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Stockholm, Sweden; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Ankara, Turkey; Recruiting
Novartis, Phone: 862-778-8300
Investigative Site, Denver, Colorado, United States; Recruiting
Novartis, Phone: 862-778-8300
Additional Information
Starting date: September 2008
Last updated: October 2, 2008
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