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

This study is not yet open for patient recruitment.
Verified by Eisai Medical Research Inc August 2005

Sponsored by: Eisai Co., Ltd.
Information provided by: Eisai Medical Research Inc Identifier: NCT00130156


To investigate efficacy and safety of Bunazosin comparing with Doxazosin under combination with Valsartin for patients with mild to moderate essential hypertension accompanied by metabolic syndrome.
Condition Intervention Phase
Blood Pressure (SBP, DBP), Lipid profile
 Drug: Bunazosin
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Study start: August 2005


Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

Inclusion Criteria

Subjects with mild to moderate essential hypertension, with the following criteria:

  1. Washout period (Week -2)

    • Male or female aged 20 to 80 years
    • SBP:140 mmHg but <180 mmHg and/or DBP:90 mmHg but <110 mmHg
    • 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 mean blood pressure SBP:140 mmHg but <180 mmHg and/or DBP:90 mmHg but <110 mmHg
    • 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 mmHg or decrease < 10 % OR DBP>=90 mmHg or decrease < 10 % comparing with AngiotensinⅡantagonist mono-therapy period.

Exclusion Criteria Subjects with the following criteria are not eligible for participation:

a)Washout period (Week -2)

  • Subjects with severe hypertension (SBP>=180 mmHg or DBP>=110 mmHg).
  • Subjects who have proven or suspected hypersensitivity to quinazoline derivatives
  • Subject 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

Location and Contact Information

Please refer to this study by identifier  NCT00130156

Yukihiko Yokobatake

      National Taiwan University Hospital., Taipei,  Taiwan

Study chairs or principal investigators

Ya-Hue Cheng,  Study Director,  Medical Affairs Department , Eisai Taiwan Inc.   

More Information

Study ID Numbers:  DTR-886-401
Last Updated:  August 12, 2005
Record first received:  August 12, 2005 Identifier:  NCT00130156
Health Authority: Taiwan: Department of Health processed this record on 2005-08-23


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