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

This study has been completed.
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00130156
First received: August 12, 2005
Last updated: May 13, 2013
Last verified: February 2011
  Purpose

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
High Blood Pressure
Drug: Bunazosin
Drug: Doxazosin
Drug: Valsartin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Week 0, Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety and tolerability. [ Time Frame: Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]

Enrollment: 93
Study Start Date: October 2005
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: Detantol-R
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.
Other Name: Diovan
Experimental: 2 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.
Other Name: Doxaben XL
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.
Other Name: Diovan

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130156

Locations
Taiwan
National Taiwan University Hospital.
Taipei, Taiwan
Sponsors and Collaborators
Eisai Inc.
Eisai Co., Ltd.
Investigators
Study Director: Ya-hui Cheng Medical Affairs Department , Eisai Taiwan Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00130156     History of Changes
Other Study ID Numbers: DTR-886-401
Study First Received: August 12, 2005
Last Updated: May 13, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Eisai Inc.:
Blood pressure
SBP
DBP

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Doxazosin
Bunazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014