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| Tracking Information | |||||
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| First Received Date ICMJE | August 12, 2005 | ||||
| Last Updated Date | June 19, 2008 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Blood Pressure [ Time Frame: Week 0, Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Blood Pressure | ||||
| Change History | Complete list of historical versions of study NCT00130156 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety and tolerability. [ Time Frame: Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension | ||||
| Official Title ICMJE | Effects of Combination Therapy With an α1-Blocker (Sustained-Release Preparation of Bunazosin or Doxazosin) in Inadequate Responders to an Angiotensin II Antagonist (Valsartan) in the Treatment of Patients With Mild to Moderate Essential Hypertension | ||||
| Brief Summary | The purpose of this study is to investigate the efficacy and safety of Bunazosin with Valsartin compared to Doxazosin with Valsartin for patients with mild to moderate essential hypertension accompanied by metabolic syndrome. |
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| Detailed Description | This clinical study will comprise a 1 to 2-week washout period, a 5-week mono therapy period with AngiotensinⅡantagonist, and an 8-week alpha blocker add-on treatment period. Total study period will be 15 weeks. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | High Blood Pressure | ||||
| Intervention ICMJE |
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| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 70 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Subjects with mild to moderate essential hypertension, with the following criteria:
Exclusion Criteria: Subjects with the following conditions are not eligible for participation: a) Washout period (Week -1 or -2)
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00130156 | ||||
| Responsible Party | Yukihiko Yokobatake, Eisai Company Limited | ||||
| Study ID Numbers ICMJE | DTR-886-401 | ||||
| Study Sponsor ICMJE | Eisai Inc. | ||||
| Collaborators ICMJE | Eisai Limited | ||||
| Investigators ICMJE |
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| Information Provided By | Eisai Inc. | ||||
| Verification Date | June 2008 | ||||
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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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