Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension
Tracking Information
Start Date ICMJE | January 2009 |
---|---|
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: February 10, 2009) | Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00841672 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 10, 2009) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety of the Combination of Aliskiren (300 mg) and Amlodipine (10 mg) Compared to Amlodipine (10 mg) Monotherapy in Patients With Moderate to Severe Hypertension |
---|---|
Official Title ICMJE | An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients |
Brief Summary | This study will compare the BP lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment. |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Condition ICMJE | Moderate to Severe Hypertension |
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 484 | ||||
---|---|---|---|---|---|
Completion Date | |||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||
Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | Czech Republic, Germany, Philippines, Romania, Russian Federation, Singapore, Spain |
Administrative Information
NCT ID ICMJE | NCT00841672 | ||||
---|---|---|---|---|---|
Responsible Party | External Affairs, Novartis | ||||
Study ID Numbers ICMJE | CSPA100A2306 | ||||
Study Sponsor ICMJE | Novartis | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Novartis |
Source: http://clinicaltrials.gov/