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Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
This study is currently recruiting participants.
Study NCT00130156   Information provided by Eisai Inc.
First Received: August 12, 2005   Last Updated: June 19, 2008   History of Changes

August 12, 2005
June 19, 2008
August 2005
September 2008   (final data collection date for primary outcome measure)
Blood Pressure [ Time Frame: Week 0, Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]
Blood Pressure
Complete list of historical versions of study NCT00130156 on ClinicalTrials.gov Archive Site
Safety and tolerability. [ Time Frame: Week 4, Week 9, Week 13. ] [ Designated as safety issue: Yes ]
Same as current
 
Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension
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

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.

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.

Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
High Blood Pressure
  • Drug: Bunazosin
  • Drug: Doxazosin
  • Drug: Valsartin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
70
 
September 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact: Yukihiko Yokobatake y-yokobatake@hhc.eisai.co.jp
Taiwan
 
NCT00130156
Yukihiko Yokobatake, Eisai Company Limited
DTR-886-401
Eisai Inc.
Eisai Limited
Study Director: Ya-hui Cheng Medical Affairs Department , Eisai Taiwan Inc.
Eisai Inc.
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP