Effects of Combination Therapy with Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients with Mild to Moderate Essential Hypertension - Article High blood pressure (hypertension)
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
|Blood Pressure (SBP, DBP), Lipid profile || Drug: Bunazosin ||Phase IV |
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Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Study start: August 2005
Subjects with mild to moderate essential hypertension, with the following criteria:
Washout period (Week -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
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
National Taiwan University Hospital., Taipei, Taiwan
Ya-Hue Cheng, Study Director, Medical Affairs Department , Eisai Taiwan Inc.
Last Updated: August 12, 2005
Record first received: August 12, 2005
ClinicalTrials.gov Identifier: NCT00130156
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-08-23
- High Blood Pressure and Kidney Disease (National Institute of Diabetes and Digestive and Kidney Diseases)