- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00130156
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
May 13, 2013 updated by: Eisai Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan
- National Taiwan University Hospital.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects with mild to moderate essential hypertension, with the following criteria:
Washout period (Week -2)
- Male or female subjects aged 20 to 80 years
- Systolic blood pressure (SBP):140 mm Hg but <180 mm Hg and/or diastolic blood pressure (DBP):90 mm Hg but <110 mm Hg
- Subjects who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol
Angiotensin II antagonist mono-therapy period (week 0)
- Subjects with systolic blood pressure >= 140 mm Hg but <180 mm Hg and/or diastolic blood pressure >= 90 mm Hg but <110 mm Hg
- Presence of any 2 of the following 4 risk factors
- Waist circumference: male > 90 cm, female > 80 cm
- Triglycerides >= 150 mg/dl
- HDL cholesterol: male < 40 mg/dl, female < 50 mg/dl
- Fasting glucose >= 110 mg/dl
Angiotensin II antagonist with add-on Bunazosin or Doxazosin treatment period (Week 5)
- SBP >=140 mm Hg or decrease < 10 % OR
- DBP >=90 mm Hg or decrease < 10 % comparing the blood pressure at the entry of the Angiotensin II antagonist mono-therapy period.
Exclusion Criteria:
Subjects with the following conditions are not eligible for participation:
a) Washout period (Week -1 or -2)
- Subjects with severe hypertension (SBP>=180 mm Hg or DBP>=110 mm Hg).
- Subjects who have proven or suspected hypersensitivity to quinazoline derivatives
- Subjects who have a history of alcohol or drug abuse.
- Subjects with past or present evidence of cancer
- Subjects who have a past history of arterial fibrillation, heart failure (LVEF<40%), acute coronary syndrome, myocardial infarction, stroke or severe arrhythmia.
- Subjects who are severely obese (BMI>30 kg/m2)
- Women who are pregnant or lactating or suspected of being pregnant.
- Subjects who have previously participated in any clinical trial of new or unapproved substances within the 12 weeks before starting of washout period
- Subjects on other anti-hypertensive or lipid-lowering medication
- Inability to return for scheduled visits or comply with any other aspect of the Protocol
- Subjects with poorly controlled diabetes mellitus (HbA1c > 10%)
- Subjects with concurrent serious hepatic or renal disorders (defined as AST and/or ALT > 3 times upper normal limit or Cr > 2mg/dl).
- Subjects who, in the opinion of the investigators, are poor medical candidates or pose any other risk for therapy with an investigational drug.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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.
Other Names:
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.
Other Names:
|
Experimental: 2
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Pressure
Time Frame: Week 0, Week 4, Week 9, Week 13.
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Week 0, Week 4, Week 9, Week 13.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability.
Time Frame: Week 4, Week 9, Week 13.
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Week 4, Week 9, Week 13.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ya-hui Cheng, Medical Affairs Department , Eisai Taiwan Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
August 12, 2005
First Submitted That Met QC Criteria
August 12, 2005
First Posted (Estimate)
August 15, 2005
Study Record Updates
Last Update Posted (Estimate)
May 14, 2013
Last Update Submitted That Met QC Criteria
May 13, 2013
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Essential Hypertension
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Doxazosin
- Bunazosin
Other Study ID Numbers
- DTR-886-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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