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

NCT00130156 | Completed Phase 4

• 1 other identifier: DTR-886-401
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Blood Pressure

Keywords

Blood pressure; SBP; DBP

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Week 0, Week 4, Week 9, Week 13.

Secondary Outcomes (1)

• Safety and tolerability.

  Week 4, Week 9, Week 13.

Study Arms (2)

1

EXPERIMENTAL

Drug: Bunazosin; Drug: Valsartin

2

EXPERIMENTAL

Drug: Doxazosin; Drug: Valsartin

Interventions

Bunazosin DRUG

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.

Also known as: Detantol-R

1

Doxazosin DRUG

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.

Also known as: Doxaben XL

2

Valsartin DRUG

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.

Also known as: Diovan

1; 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Co., Ltd.: collaborator

Study Sites (1)

National Taiwan University Hospital.

Taipei, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

bunazosin; Doxazosin; Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Ya-hui Cheng

  Medical Affairs Department , Eisai Taiwan Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: October 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: March 1, 2009
• Last Updated: May 14, 2013

Record last verified: 2011-02

Locations

TW (1)