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

August 12, 2005
May 13, 2013
October 2005
September 2008   (final data collection date for primary outcome measure)
Blood Pressure [ Time Frame: Week 0, Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00130156 on ClinicalTrials.gov Archive Site
Safety and tolerability. [ Time Frame: Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
High Blood Pressure
  • 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: 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
  • Experimental: 1
    Interventions:
    • Drug: Bunazosin
    • Drug: Valsartin
  • Experimental: 2
    Interventions:
    • Drug: Doxazosin
    • Drug: Valsartin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
March 2009
September 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00130156
DTR-886-401
Not Provided
Eisai Inc.
Eisai Inc.
Eisai Co., Ltd.
Study Director: Ya-hui Cheng Medical Affairs Department , Eisai Taiwan Inc.
Eisai Inc.
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP