Clinical trial NCT00130156: Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Blood Pressure
Keywords: Blood pressure
SBP
DBP
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eisai Co., Ltd.
First posted: 2005-08-15
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: Week 0, Week 4, Week 9, Week 13.
Secondary outcomes:
measure: Safety and tolerability.
timeFrame: Week 4, Week 9, Week 13.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital.
Study officials:
affiliation: Medical Affairs Department , Eisai Taiwan Inc.
name: Ya-hui Cheng
role: STUDY_DIRECTOR
References: