Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia - Tabular View

Tracking Information

First Received Date ^ICMJE

August 7, 2008

Last Updated Date

August 10, 2009

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Expression of alpha-1 adrenoceptor [ Time Frame: before treatment and 12mos and 24 mos after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00730418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Advers events [ Time Frame: before treatment and 3mos, 12mos, and 24mos after treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia

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 methologies such as

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: Doxazosin

Study Arms / Comparison Groups

Experimental: doxazosin 4mg group
Experimental: doxazosin 8mg group

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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
Baterial 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 cormorbidities unable to perform long-term trial
seems not to be appropriate to this study because of any other reasons

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kyu-Sung Lee, Ph.D., M.D.	+82-2-3410-3554	ksleedr@skku.edu
Contact: Deok Hyun Han, M.D.	+82-2-3410-3559	deokhyun.han@samsung.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00730418

Responsible Party

Kyu-Sung Lee/Professor, Samsung Medical Center

Study ID Numbers ^ICMJE

2006-08-118

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kru-Sung Lee, Ph.D., M.D.

Samsung Medical Center

Information Provided By

Samsung Medical Center

Verification Date

August 2009

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