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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00130156
Other study ID # DTR-886-401
Secondary ID
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 Angiotensinâ…ˇantagonist, 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


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
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