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Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension

Primary Purpose

High Blood Pressure

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Bunazosin
Doxazosin
Valsartin
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Blood Pressure focused on measuring Blood pressure, SBP, DBP

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Blood Pressure

Secondary Outcome Measures

Safety and tolerability.

Full Information

First Posted
August 12, 2005
Last Updated
May 13, 2013
Sponsor
Eisai Inc.
Collaborators
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00130156
Brief Title
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
Collaborators
Eisai Co., Ltd.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
Blood pressure, SBP, DBP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bunazosin
Other Intervention Name(s)
Detantol-R
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxazosin
Other Intervention Name(s)
Doxaben XL
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Valsartin
Other Intervention Name(s)
Diovan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Time Frame
Week 0, Week 4, Week 9, Week 13.
Secondary Outcome Measure Information:
Title
Safety and tolerability.
Time Frame
Week 4, Week 9, Week 13.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ya-hui Cheng
Organizational Affiliation
Medical Affairs Department , Eisai Taiwan Inc.
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital.
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension

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