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Tracking Information | |||||
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First Received Date † | January 7, 2009 | ||||
Last Updated Date | April 20, 2009 | ||||
Start Date † | January 2009 | ||||
Current Primary Outcome Measures † |
Change from baseline in systolic blood pressure at peak exercise (85% of the maximal predicted heart rate) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00819767 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise | ||||
Official Title † | An Eight-Week, Randomized, Double-Blind, Parallel-Group, Pilot Study to Evaluate the Efficacy and Safety of Aliskiren 300 mg in Comparison With Valsartan 320 mg in Patients With Mild to Moderate Hypertension During Exercise After a Missed Dose | ||||
Brief Summary | This study will compare the blunting effect of aliskiren and valsartan monotherapies on exercise-induced rises in SBP in patients with mild to moderate essential hypertension. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment | ||||
Condition † | Hypertension | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 60 | ||||
Completion Date | |||||
Estimated Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | China, Czech Republic, Hungary, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00819767 | ||||
Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
Secondary IDs †† | |||||
Study Sponsor † | Novartis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Novartis | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |