Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to compare the efficacy of ASP4901 with placebo in patients with benign prostatic hyperplasia. The safety and tolerability of ASP4901 will also be evaluated.


Clinical Trial Description

This is a multicenter, randomized, parallel-group, placebo-controlled, active-referenced, double-blind study. After obtaining the written consent, patients meeting the eligibility criteria at the preliminary enrollment will receive oral administration of placebo in a single-blinded manner (single-blind placebo run-in period). Then, patients meeting the eligibility criteria at the main enrollment will receive drug or placebo (double-blind treatment period) for 4 weeks. Furthermore, patients will be followed up for 1 week to confirm the safety of the study drugs after the treatment period (safety follow-up period). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02038868
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 2
Start date July 22, 2013
Completion date April 4, 2014

See also
  Status Clinical Trial Phase
Completed NCT01942551 - Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride Phase 1
Completed NCT01436877 - Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia N/A
Completed NCT02822924 - Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia N/A
Completed NCT02390882 - A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HGP0412 and HIP1402 in Patients With BPH Phase 3
Completed NCT02839122 - A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects Phase 1
Not yet recruiting NCT01861041 - Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy. Phase 4
Completed NCT02332538 - HoLEP vs. Greenlight 532nm-laser PVEP vs. Bipolar TURP in Management of Moderate/ Large BPH N/A
Completed NCT01835860 - Prostatic Artery Embolization for Benign Prostatic Hyperplasia Phase 2/Phase 3
Completed NCT01665586 - Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study N/A
Completed NCT02506465 - Pivotal Study to Assess the Safety and Effectiveness of the iTind Device N/A
Completed NCT01675895 - Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration Phase 4
Completed NCT02483819 - Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients N/A
Recruiting NCT02827578 - Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia Phase 3
Completed NCT02352311 - Safety and Pharmacokinetic Characteristics of DKF-313 Phase 1
Completed NCT01627522 - Evaluation of Finastride Effect in Different Dosage on the Amount of Perioperative Bleeding in Transurthral Resection of Prostate Phase 2/Phase 3
Completed NCT01494337 - Holmium Laser Enucleation of Prostate(HOLEP) vs Greenlight(XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP) Phase 4
Completed NCT01952912 - Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates N/A
Active, not recruiting NCT01736033 - Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients Phase 4
Recruiting NCT02021032 - Post-Marketing Study Using PROLIEVE® for the Treatment of Benign Prostatic Hyperplasia (BPH) Phase 4
Completed NCT00861588 - Effects of Isoflavone in Patients With Watchful Waiting Benign Prostate Hyperplasia N/A