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Sponsors and Collaborators: |
Eisai Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00130156 |
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.
Condition | Intervention | Phase |
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High Blood Pressure |
Drug: Bunazosin Drug: Doxazosin Drug: Valsartin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 70 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Bunazosin
Patients will be randomized to the add-on treatment with Bunazosin (Detantol-R) 3 mg once-daily after breakfast for a total of eight weeks.
Drug: Valsartin
After wash-out period, the eligible subjects will be treated with Valsartin (Diovan) 80 mg as the mono therapy for 5 weeks. If the blood pressures are inadequately responded, then the patients will be randomized to either Bunazosin (Detantol-R) or Doxazosin (Doxaben XL) along with Valsartin as the add-on treatment for 8 weeks.
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2: Experimental |
Drug: Doxazosin
Patients will be randomized to the add-on treatment with Doxazosin (Doxaben XL) 4 mg once-daily after breakfast for a total of eight weeks.
Drug: Valsartin
After wash-out period, the eligible subjects will be treated with Valsartin (Diovan) 80 mg as the mono therapy for 5 weeks. If the blood pressures are inadequately responded, then the patients will be randomized to either Bunazosin (Detantol-R) or Doxazosin (Doxaben XL) along with Valsartin as the add-on treatment for 8 weeks.
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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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects with mild to moderate essential hypertension, with the following criteria:
Washout period (Week -2)
Angiotensin II antagonist mono-therapy period (week 0)
Angiotensin II antagonist with add-on Bunazosin or Doxazosin treatment period (Week 5)
Exclusion Criteria:
Subjects with the following conditions are not eligible for participation:
a) Washout period (Week -1 or -2)
Contact: Yukihiko Yokobatake | y-yokobatake@hhc.eisai.co.jp |
Taiwan | |
National Taiwan University Hospital. | Recruiting |
Taipei, Taiwan |
Study Director: | Ya-hui Cheng | Medical Affairs Department , Eisai Taiwan Inc. |
Responsible Party: | Eisai Company Limited ( Yukihiko Yokobatake ) |
Study ID Numbers: | DTR-886-401 |
Study First Received: | August 12, 2005 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00130156 |
Health Authority: | Taiwan: Department of Health |
Blood pressure SBP DBP |
Bunazosin Vascular Diseases Essential hypertension Angiotensin II |
Aniridia Valsartan Doxazosin Hypertension |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs Adrenergic Antagonists |
Cardiovascular Diseases Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions |