Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00778921 |
This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Amlodipine 10 mg Drug: Aliskiren/Amlodipine 150/10 mg Drug: Aliskiren/Amlodipine 300/10 mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Randomized, Eight Week Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / Amlodipine (150/10 mg and 300/10 mg) in Comparison With Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 10 mg Monotherapy |
Estimated Enrollment: | 726 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Amlodipine 10 mg
|
Drug: Amlodipine 10 mg
Amlodipine 10 mg
|
2: Experimental
Aliskiren/Amlodipine 150/10 mg
|
Drug: Aliskiren/Amlodipine 150/10 mg
Aliskiren/Amlodipine 150/10 mg
|
3: Experimental
Aliskiren/Amlodipine 300/10 mg
|
Drug: Aliskiren/Amlodipine 300/10 mg
Aliskiren/Amlodipine 300/10 mg
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis | 862-778-8300 |
Argentina | |
Investigative Site | Recruiting |
Buenos Aires, Argentina | |
Contact: Novartis 862-778-8300 | |
Germany | |
Investigative Site | Recruiting |
Berlin, Germany | |
Contact: Novartis 862-778-8300 | |
Norway | |
Investigative Site | Recruiting |
Oslo, Norway | |
Contact: Novartis 862-778-8300 | |
Poland | |
Investigative Site | Recruiting |
Warsaw, Poland | |
Contact: Novartis 862-778-8300 | |
Slovakia | |
Investigative Site | Recruiting |
Bratislava, Slovakia | |
Contact: Novartis 862-778-8300 | |
Sweden | |
Investigative Site | Recruiting |
Stockholm, Sweden | |
Contact: Novartis 862-778-8300 | |
Turkey | |
Investigative Site | Recruiting |
Ankara, Turkey | |
Contact: Novartis 862-778-8300 |
Study Chair: | Novartis | N |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CSPA100A2304 |
Study First Received: | October 23, 2008 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00778921 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Germany: Federal Institute for Drugs and Medical Devices; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Medical Products Agency; Slovakia: State Institute for Drug Control; Turkey: Ministry of Health |
Aliskiren Amlodipine Non-responder to Amlodipine |
Calcium, Dietary Vasodilator Agents Essential Hypertension Vascular Diseases Calcium Channel Blockers |
Cardiovascular Agents Antihypertensive Agents Amlodipine Hypertension |
Membrane Transport Modulators Vasodilator Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Vascular Diseases Calcium Channel Blockers |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Amlodipine Hypertension |