Clinical Trials Logo
  1. Home
  2. Prostatic Hyperplasia
  3. NCT00793819

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Prostatic Hyperplasia Clinical Trial

Official title:
A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Clinical Trial Summary

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Clinical Trial Description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00793819
Study type Interventional
Source Watson Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date January 2009
Completion date October 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT02578953 - Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects Phase 1
Terminated NCT02396420 - Prostate Artery Embolization as a Treatment for Benign Prostatic Hyperplasia in Men With Prostates Larger Than 90 Grams Phase 2
Terminated NCT04398966 - Prostatic Artery Embolization vs Medication for Benign Prostatic Hyperplasia N/A
Not yet recruiting NCT06452927 - EEP in Patients With Urodynamically Proven DU/DA N/A
Completed NCT02947958 - Teleconsultation in Counter-reference Between Tertiary and Primary Care for Patients With Benign Prostatic Hyperplasia N/A
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT00427882 - Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study Phase 4
Completed NCT02244320 - Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin) N/A
Completed NCT01254071 - A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry. Phase 1
Recruiting NCT04108871 - Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men N/A
Recruiting NCT05686525 - Clinical Trial on the Effectiveness of TUMT Compared to PAE in Reducing Severe LUTS in Men With BPH N/A
Completed NCT01957189 - This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples Phase 1
Completed NCT00316732 - Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS N/A
Completed NCT02715401 - PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers Phase 1
Recruiting NCT02278679 - Digital Rectal Exam Proficiency Tool N/A
Completed NCT01376258 - Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database N/A
Completed NCT01482676 - The Role of microRNAs in Organ Remodeling in Lower Urinary Tract Dysfunction N/A
Completed NCT00822952 - Prostate Mechanical Imager (PMI) Clinical Bridging Study N/A
Completed NCT00527605 - Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH) Phase 3
Terminated NCT00563654 - Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up N/A