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

Sponsor:	Eisai Inc.
Collaborator:	Eisai Co., Ltd.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00130156

Purpose

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.

Condition	Intervention	Phase
High Blood Pressure	Drug: Bunazosin Drug: Doxazosin Drug: Valsartin	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Doxazosin Doxazosin mesylate Bunazosin Valsartan

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Blood Pressure [ Time Frame: Week 0, Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability. [ Time Frame: Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]

Enrollment:	93
Study Start Date:	October 2005
Study Completion Date:	March 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	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. Other Name: Detantol-R Drug: 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. Other Name: Diovan
Experimental: 2	Drug: 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. Other Name: Doxaben XL Drug: 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. Other Name: Diovan

Arms

Assigned Interventions

Experimental: 1

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.

Other Name: Detantol-R

Drug: 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.

Other Name: Diovan

Experimental: 2

Drug: 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.

Other Name: Doxaben XL

Drug: 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.

Other Name: Diovan

Detailed 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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130156

Locations

Taiwan
National Taiwan University Hospital.
Taipei, Taiwan

Sponsors and Collaborators

Eisai Inc.

Eisai Co., Ltd.

Investigators

Study Director:

Ya-hui Cheng

Medical Affairs Department , Eisai Taiwan Inc.

More Information

No publications provided

Responsible Party:	Yukihiko Yokobatake, Eisai Company Limited
ClinicalTrials.gov Identifier:	NCT00130156 History of Changes
Other Study ID Numbers:	DTR-886-401
Study First Received:	August 12, 2005
Last Updated:	February 24, 2011
Health Authority:	Taiwan: Department of Health

Keywords provided by Eisai Inc.:

Blood pressure
SBP
DBP

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Bunazosin
Doxazosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012