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

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

      • Taipei, Taiwan
        • National Taiwan University Hospital.

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:

  1. 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
  2. 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
  3. 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:
  • Detantol-R
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:
  • Diovan
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:
  • Diovan
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:
  • Doxaben XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: Week 0, Week 4, Week 9, Week 13.
Week 0, Week 4, Week 9, Week 13.

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability.
Time Frame: Week 4, Week 9, Week 13.
Week 4, Week 9, Week 13.

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

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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