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A Study to Evaluate the Efficacy and Safety of ASP4901 in Patients With Benign Prostate Hyperplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038868
First Posted: January 17, 2014
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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.

Condition Intervention Phase
Benign Prostate Hyperplasia Drug: ASP4901 Drug: Tamsulosin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Active-Referenced, Parallel-Group Comparative Study in Patients With Benign Prostatic Hyperplasia

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in total IPSS (International Prostate Symptom Score) [ Time Frame: baseline and at the final evaluation (up to 5 weeks) ]

Secondary Outcome Measures:
  • Change from baseline in each symptom score of IPSS [ Time Frame: baseline and at the final evaluation (up to 5 weeks) ]
  • Change from baseline in IPSS QOL (quality of life) score [ Time Frame: baseline and at the final evaluation (up to 5 weeks) ]
  • Proportion of IPSS responder [ Time Frame: baseline and at the final evaluation (up to 5 weeks) ]
    "IPSS responder" is defined as 25% improvement in IPSS

  • Plasma concentration of ASP4901 [ Time Frame: up to 5 weeks ]
    only for ASP4901 group

  • Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs [ Time Frame: up to 5 weeks ]

Enrollment: 320
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP4901 group Drug: ASP4901
oral
Placebo Comparator: Placebo group Drug: Placebo
oral
Active Comparator: Tamsulosin group Drug: Tamsulosin
oral
Other Names:
  • YM617
  • Harnal

Detailed 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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysuria associated with BPH for at least 12 weeks before providing consent
  • a total IPSS core of 13 or higher
  • a QOL score of 3 or higher
  • a maximum urinary flow rate (Qmax) of ≥4 mL/sec and <15 mL/sec.
  • a prostate volume of ≥20 mL.

Exclusion Criteria:

  • A postvoid residual volume (PVR) of >350 mL
  • A previous or concurrent symptomatic urinary tract infection within 4 weeks of the study
  • A cataract operation scheduled to be performed during the study period
  • Previous or concurrent clinically relevant cardiovascular or cerebrovascular disorder within 24 weeks prior to the study
  • Hypersensitivity to ASP4901 or tamsulosin hydrochloride
  • Presence of serious hepatic diseases, renal diseases, immunological diseases, or pulmonary diseases that are clinically relevant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038868


Locations
Japan
Kansai, Japan
Kanto, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02038868     History of Changes
Other Study ID Numbers: 4901-CL-0201
First Submitted: January 15, 2014
First Posted: January 17, 2014
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Astellas Pharma Inc:
BPH
ASP4901

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents