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High Blood PressurePhase 4NCT00130156

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

A Phase 4 study testing Bunazosin, Doxazosin and Valsartin in people with High Blood Pressure, run by Eisai Inc. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
High Blood Pressure
What is being tested?
Bunazosin, Doxazosin and Valsartin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteTaiwan
Study dates
Oct 2005to Mar 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • Subjects with the following conditions are not eligible for participation：
  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital.

    Taipei

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Bunazosin, Doxazosin, Valsartin
Keywords
Blood pressure, SBP, DBP
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BunazosinDrug

    Also called Detantol-R

    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.

  • DoxazosinDrug

    Also called Doxaben XL

    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.

  • ValsartinDrug

    Also called Diovan

    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.

Study groups in NCT00130156
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Bunazosin; Drug: Valsartin
2ExperimentalNot described
Receives: Drug: Doxazosin; Drug: Valsartin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Measured: Week 0, Week 4, Week 9, Week 13.

Secondary outcomes (1)

  1. Safety and tolerability.

    Measured: Week 4, Week 9, Week 13.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionSep 2008
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00130156
Sponsor's protocol ID
DTR-886-401
Status last verified
Feb 2011
First submitted
12 Aug 2005
Last updated
14 May 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bunazosin, Doxazosin and Valsartin in people with High Blood Pressure, run by Eisai Inc. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Week 0, Week 4, Week 9, Week 13.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00130156.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.

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