A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00510406

Purpose

The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.

Condition	Intervention	Phase
Lower Urinary Tract Symptoms Prostatic Hyperplasia	Drug: tamsulosin hydrochloride Drug: solifenacin succinate Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/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 Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

Resource links provided by NLM:

Drug Information available for: Succinic acid Tamsulosin Tamsulosin hydrochloride Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess efficacy, safety, tolerability and PK of the combination of solifenacin succinate and tamsulosin hydrochloride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	919
Study Start Date:	January 2007
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: Placebo Placebo
B: Active Comparator	Drug: solifenacin succinate antimuscarinic
C: Active Comparator	Drug: solifenacin succinate antimuscarinic
D: Active Comparator	Drug: solifenacin succinate antimuscarinic
E: Active Comparator	Drug: tamsulosin hydrochloride Alphablocker
F: Active Comparator	Drug: tamsulosin hydrochloride Alphablocker Drug: solifenacin succinate antimuscarinic
G: Active Comparator	Drug: tamsulosin hydrochloride Alphablocker Drug: solifenacin succinate antimuscarinic
H: Active Comparator	Drug: tamsulosin hydrochloride Alphablocker Drug: solifenacin succinate antimuscarinic

Detailed Description:

Placebo Solifenacin succinate Tamsulosin hydrochloride Tamsulosin hydrochloride + solifenacin succinate

The primary comparison will be the combination treatment with tamsulosin hydrochloride monotherapy.

Other comparisons will be:

Placebo and combination treatment. Solifenacin monotherapy and combination treatment

Eligibility

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

Criteria

Inclusion Criteria:

male patients with LUTS associated with BPH diagnosed > 3 months
IPSS score > 13
voiding and storage symptoms
maximum flow rate of > 4 mL/s and < 15 mL/s

Exclusion Criteria:

post void residual volume > 200 mL
symptomatic urinary tract infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510406

Show 98 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma Europe BV

More Information

Additional Information:

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	905-CL-052, EudraCT number: 2006-002072-18
Study First Received:	July 31, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00510406 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; France: Afssaps - French Health Products Safety Agency; 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: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Norway: Norwegian Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Astellas Pharma Inc:

Lower Urinary Tract Symptoms
Treatment
Solifenacin succinate
Tamsulosin hydrochloride
Prostatic Hyperplasia

Additional relevant MeSH terms:

Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Cholinergic Agents
Genital Diseases, Male

Pharmacologic Actions
Muscarinic Antagonists
Hyperplasia
Pathologic Processes
Prostatic Hyperplasia
Therapeutic Uses
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on March 18, 2010