Effects of Chronic Use of Doxazosin in Men With Benign Pr... | NCT00730418

Studies
Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

NCT00730418

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Aug 26, 2010Estimated

Enrollment

25Actual

Phase

Not Applicable

Conditions

Benign Prostatic Hyperplasia

Interventions

Doxazosin
Doxazosin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 7, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2010

Last Update Posted Date

Aug 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

Detailed Description

To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as

Real-time RT-PCR
Radioligand receptor binding
Western blot
Immunohistochemistry

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
doxazosin 4mg	Experimental	doxazosin 4mg group	Drug: Doxazosin
doxazosin 8mg	Experimental	doxazosin 8mg group	Drug: Doxazosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxazosin	Drug	Treatment with doxazosin 4mg daily for 24 mos	doxazosin 4mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of alpha-1 adrenoceptor		before treatment and 12mos and 24 mos after treatment

Secondary Outcomes

Measure	Description	Time Frame
International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events		before treatment and 3mos, 12mos, and 24mos after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

50 yrs or greater
International prostatic symptom score >= 8
Maximal flow rate < 15mL/sec
baseline PSA 2.5-10 ng/mL
Pathologically proven BPH
No medication history for BPH
Able to give fully informed consent

Exclusion Criteria:

Previous use of alpha-blocker, 5-alpha reductase inhibitor
Previous surgery for BPH
Urologic cancer history
Urethral stricture
baseline PSA > 10ng/mL
BP < 90/70 mmHg
Orthotopic hypotension with syncope
Serum Cr > 2.0 mg/dl, alanine aminotransferase > 1.5 times of normal limit
Bacterial prostatitis within 1 year
Urinary tract infection(UTI) more than 2 times within 1 year
Active UTI or prostate biopsy within 1 month
Unable to void
Ped use because of incontinence
Hypersensitivity to alpha-blocker that include quinazoline
Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months
Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)
Psychiatric problem
Alcohol abuse or other drug abuse history
Severe comorbidities unable to perform long-term trial
seems not to be appropriate to this study because of any other reasons

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kru-Sung Lee, Ph.D., M.D.	Samsung Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017292	Doxazosin

Ancestor Terms

ID	Term
D011224	Prazosin
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided