A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime... | NCT00379067

Studies
A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.

NCT00379067

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 10, 2014Estimated

Enrollment

882Actual

Phase

Phase 4

Conditions

Benign Prostatic Hyperplasia

Interventions

Tamsulosin OCAS
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

Sep 19, 2006

First Submission Date that Met QC Criteria

Sep 19, 2006

First Posted Date

Sep 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2014

Last Update Posted Date

Oct 10, 2014Estimated

Name	Class
Astellas Pharma Europe Ltd.	INDUSTRY
Boehringer Ingelheim	INDUSTRY

Description Module

Brief Summary

Randomized, double-blind, placebo-controlled study with two treatment arms (Tamsulosin OCAS 0.4 mg & placebo). The study comprises a 2-week placebo run-in followed by a 12-week treatment period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

882Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Tamsulosin OCAS tablet	Drug: Tamsulosin OCAS
2	Placebo Comparator	Placebo tablet	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tamsulosin OCAS	Drug	Adrenoceptor antagonist	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from baseline to week 12 in mean number of nocturnal voids		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
The change from baseline to week 12 in mean hours of undisturbed sleep, defined as the time from falling asleep to first awakening to void		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as having LUTS associated with BPH
On average, at least 2 voids per night over the last week
A maximum of 4 hours of undisturbed sleep expected per night (night time is defined as the time from going to bed with the purpose of sleeping until waking up with the purpose of getting up)

Exclusion Criteria:

Subject is currently taking diuretics
Subjects who work shift hours and whose hours of work include any time between 23.00 and 06.00h

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Use Central Contact	Medical Affairs Europe, Astellas Pharma Europe Limited, Lovett House, Lovett Road, Staines Middlesex TW 18 3AZ	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia
D053158	Nocturia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided