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Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01018511
First received: November 19, 2009
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  Purpose

Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin and solifenacin compared to monotherapy of tamsulosin in the treatment of males with LUTS associated with BPH with a substantial storage component.


Condition Intervention Phase
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
 Drug: Placebo
Drug: tamsulosin hydrochloride monotherapy
Drug: tamsulosin hydrochloride / solifenacin succinate fixed dose combinations
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline to endpoint in total International Prostate Symptom Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in TUS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to endpoint in data from micturition diary, I-PSS questionnaire, OAB-q, EQ-5D, PGI and CGI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • PK variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 1334
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1. placebo Drug: Placebo
oral
Active Comparator: 2. Tamsulosin monotherapy Drug: tamsulosin hydrochloride monotherapy
oral
Other Name: YM617
Experimental: 3. Tamsulosin / solifenacin combi, low dose Drug: tamsulosin hydrochloride / solifenacin succinate fixed dose combinations
oral
Other Name: EC905
Experimental: 4. Tamsulosin / solifenacin combi, high dose Drug: tamsulosin hydrochloride / solifenacin succinate fixed dose combinations
oral
Other Name: EC905

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voiding and storage symptoms diagnosed as LUTS associated with BPH for ≥ 3 months
  • A total I-PSS of ≥13
  • A maximum urinary flow rate of ≥4.0 mL/s and ≤12.0 mL/s, with voided volume of ≥120 mL during free flow
  • A micturition frequency of ≥8 and at least 2 episodes of urgency with Patient Perception of the Intensity of Urgency Scale grade 3 or 4 per day on average on the 3 day micturition diary (at randomization)

Exclusion Criteria:

  • Any significant Post Void Residual volume (>150 mL)
  • A prostate with estimated weight ≥75 g as assessed by transvesical or transrectal ultrasound
  • Evidence of a symptomatic urinary tract infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018511

  Show 118 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01018511     History of Changes
Other Study ID Numbers: 905-CL-055, 2008-001211-37
Study First Received: November 19, 2009
Last Updated: September 13, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Lower Urinary Tract Symptoms
Treatment
Solifenacin succinate
Tamsulosin hydrochloride OCAS
Benign Prostatic Hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 19, 2013