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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00797316 |
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with HCTZ compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure (msSBP) ≥ 160 mm Hg and < 200 mm Hg).
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Aliskiren plus Hydrochlorothiazide Drug: Aliskiren |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An 8-Week Randomized, Double-Blind, Parallel-Group, Multi-Center, Forced-Titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension |
Estimated Enrollment: | 524 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Aliskiren plus Hydrochlorothiazide
|
Drug: Aliskiren plus Hydrochlorothiazide
Aliskiren plus HCTZ 150/12.5 mg: 1 week Aliskiren plus HCTZ 300/25 mg: 7 weeks
|
2: Active Comparator
Aliskiren 150mg: 1 week Aliskiren 300mg: 7 weeks
|
Drug: Aliskiren
Aliskiren 150mg: 1 week Aliskiren 300mg: 7 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:
Exclusion Criteria:
Contact: Novartis | 862-778-8300 |
United States, Illinois | |
Investigative Site | Recruiting |
North Chicago, Illinois, United States, 63110 | |
Contact: Novartis 862-778-8300 | |
United States, Missouri | |
Investigative Site | Recruiting |
Springfield, Missouri, United States, 65807 | |
Contact: Novartis 862-778-8300 | |
United States, New Jersey | |
Investigative Site | Recruiting |
Toms River, New Jersey, United States, 08753 | |
Contact: Novartis 862-778-8300 | |
Investigative Site | Recruiting |
Margate City, New Jersey, United States, 08402 | |
Contact: Novartis 862-778-8300 | |
United States, New York | |
Investigative Site | Recruiting |
Bronx, New York, United States, 10469 | |
Contact: Novartis 862-778-8300 | |
United States, Pennsylvania | |
Investigative Site | Recruiting |
Morrisville, Pennsylvania, United States, 19067 | |
Contact: Novartis 862-778-8300 |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPP100A2410 |
Study First Received: | November 24, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797316 |
Health Authority: | United States: Food and Drug Administration |
Hypertension Metabolic Syndrome aliskiren hydrochlorothiazide |
systolic blood pressure diastolic blood pressure stage 2 |
Vascular Diseases Hydrochlorothiazide Hypertension |
Disease Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Membrane Transport Modulators Pathologic Processes Natriuretic Agents Therapeutic Uses Syndrome Cardiovascular Diseases |