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

Eisai

Status and phase: Completed; Phase 4

Conditions: High Blood Pressure

Treatments: Drug: Bunazosin; Drug: Valsartin; Drug: Doxazosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00130156

DTR-886-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Valsartin

Drug: Bunazosin

2

Experimental group

Treatment:

Drug: Doxazosin

Drug: Valsartin