Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00542269 |
This proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy.
Condition | Intervention | Phase |
---|---|---|
Hypertension With Metabolic Syndrome |
Drug: ramipril/amlodipine (10/10 mg) Drug: aliskiren/amlodipine (300/10 mg) Drug: aliskiren/ramipril/amlodipine (300/10/10mg) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Ramipril/Amlodipine (300/10/10mg) Compared to the Combinations of Ramipril/Amlodipine (10/10 mg) and Aliskiren/Amlodipine (300/10 mg) in Patients With Essential Hypertension and Metabolic Syndrome Not Adequately Responsive to Amlodipine 10 mg. |
Estimated Enrollment: | 846 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
aliskiren/ramipril/amlodipine (300/10/10mg)
|
Drug: aliskiren/ramipril/amlodipine (300/10/10mg)
aliskiren/ramipril/amlodipine (300/10/10mg)
|
2: Active Comparator
ramipril/amlodipine (10/10 mg)
|
Drug: ramipril/amlodipine (10/10 mg)
ramipril/amlodipine
|
3: Experimental
aliskiren/amlodipine (300/10 mg)
|
Drug: aliskiren/amlodipine (300/10 mg)
aliskiren/amlodipine (300/10 mg)
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis | +41 61 324 1111 |
United Kingdom | |
Addenbrookes Hospital | Recruiting |
Cambridge, United Kingdom | |
Contact: Novartis +41 61 324 1111 |
Study Chair: | Novartis | Novartis Great Britian |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSPP100AGB01 |
Study First Received: | October 9, 2007 |
Last Updated: | January 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00542269 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Hypertension Metabolic Syndrome Dual combination therapy |
Triple combination therapy Aliskiren Direct Renin inhibitor |
Calcium, Dietary Vascular Diseases Essential hypertension |
Ramipril Amlodipine Hypertension |
Vasodilator Agents Disease Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Pathologic Processes Syndrome Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |