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

High Blood Pressure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130156
• Other study ID #: DTR-886-401
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2005
• Last updated: May 13, 2013
• Start date: October 2005
• Est. completion date: March 2009

Study information

• Verified date: February 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital.	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Eisai Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure		Week 0, Week 4, Week 9, Week 13.	Yes
Secondary	Safety and tolerability.		Week 4, Week 9, Week 13.	Yes