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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 7, 2006 | ||||
| Last Updated Date | July 6, 2007 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (Wk 4 and Wk 8) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00409760 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension. | ||||
| Official Title ICMJE | A Randomized, Double-Blind, Multicenter, Multifactorial, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients. | ||||
| Brief Summary | This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | Drug: valsartan+amlodipine combination, valsartan, amlodipine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 1850 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00409760 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CVAA489A2201 | ||||
| Study Sponsor ICMJE | Novartis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Novartis | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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