Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms (Neptune II)

November 12, 2024 updated by: Astellas Pharma Europe B.V.

An Open-label, Long Term, Multi-center Study to Assess the Safety and Efficacy of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label extension study following the double blind 905-CL-055 study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1067

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
      • Vienna, Austria, 1090
  • Belarus
      • Minsk, Belarus, 220036
      • Minsk, Belarus, 220119
      • Minsk, Belarus, 223040
  • Belgium
      • Antwerp, Belgium, 2020
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
      • Liege 1, Belgium, 4000
  • Czechia
      • Hradec Kralove, Czechia, 500 02
      • Ostrava, Czechia, 700 30
      • Plzen, Czechia, 301 24
      • Roudnice nad Labem, Czechia, 413 01
      • Uherske Hradiste, Czechia, 686 08
      • Usti nad Labem, Czechia, 400 01
      • Zd'ar nad Sazavou, Czechia, 591 01
  • France
      • Colmar Cedex, France, 68024
      • Montlucon, France, 03100
      • Orleans cedex 2, France, 45067
      • Paris, France, 75010
      • Paris Cedex 10, France, 75020
      • Pierre Benite, France, 69495
  • Germany
      • Bautzen, Germany, 02625
      • Frankfurt, Germany, 65933
      • Ganderkesee, Germany, 27777
      • Hagenow, Germany, 19230
      • Halle Saale, Germany, 06132
      • Hamburg, Germany, 20253
      • Henningsdorf, Germany, 16761
      • Hettstedt, Germany, 06333
      • Koblenz, Germany, 56068
      • Leipzig, Germany, 04105
      • Leipzig, Germany, 04109
      • Lutherstadt Eisleben, Germany, 06295
      • Neustadt in Sachsen, Germany, 01844
      • Radebeul, Germany, 01445
      • Sachsen, Germany, 06526
      • Trier, Germany, 54290
      • Uetersen, Germany, 25436
  • Italy
      • Avellino, Italy, 83100
      • Catanzaro, Italy, 88100
      • Palermo, Italy, 90146
      • Treviglio, Italy, 24047
  • Netherlands
      • Amsterdam, Netherlands, 100 AD
      • Apeldoorn, Netherlands, 7334 DZ
      • Doetinchem, Netherlands, 7009 BL
      • Maastricht, Netherlands, 6229 HX
      • Sneek, Netherlands, 8600 BA
      • Tilburg, Netherlands, 5022 GC
      • Winterswijk, Netherlands, 7101 BN
  • Poland
      • Bielsko-Biala, Poland, 43-300
      • Bydgoszcz, Poland, 85-094
      • Krakow, Poland, 31-530
      • Pulawy, Poland, 24-100
      • Warsaw, Poland, 02-005
      • Wiecbork, Poland, 89-410
  • Slovakia
      • Nitra, Slovakia, 949 01
      • Piestany, Slovakia, 921 02
      • Presov, Slovakia, 080 01
      • Skalica, Slovakia, 909 82
      • Trencin, Slovakia, 911 01
  • United Kingdom
      • Cardiff, United Kingdom, CF14 5GJ
      • Chorley, United Kingdom, PR7 7NA
      • Liverpool, United Kingdom, L22 0LG
      • Northwood, United Kingdom, HA6 2RN
      • Oxford, United Kingdom, OX3 7LJ
      • Reading, United Kingdom, RG2 7AG
      • Sheffield, United Kingdom, S10 2JF
      • Taunton, United Kingdom, TA1 5DA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Completion of 12 weeks double-blind treatment in Study 905-CL-055

Exclusion Criteria:

  • Any significant PVR volume (>150 mL)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Total Group
Participants who received at least one dose of open-label fixed dose combination (FDC) treatment
Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
oral
Other Names:
  • Vesomni
  • EC905
Drug: tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
oral
Other Names:
  • EC905

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
Safety is monitored by collecting AEs, which include abnormal lab parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A serious AE (SAE) was an AE resulting in death, persistent or significant disability/incapacity or congenital anomaly/birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity (mild-no disruption of normal daily activities, moderate-affected normal daily activities or severe-inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after the intake of first dose of double-blind study drug (if on FDC in 905-CL-055) or after first open-label dose until 30 days after the last dose of open-label study drug (in 905-CL-057).
From first dose of double-blind study drug (if on FDC in 905-CL-055) or first open-label dose up to 30 days after last dose of open-label study drug (in 905-CL-057) (up to 56 weeks)
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume
Time Frame: Baseline and up to 52 weeks of FDC treatment
PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)
Time Frame: Baseline and up to 52 weeks of FDC treatment
Qmax during a micturition (urination) was recorded using uroflowmetry.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)
Time Frame: Baseline and up to 52 weeks of FDC treatment
Qmean during a micturition (urination) was recorded using uroflowmetry.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS)
Time Frame: Baseline and up to 52 weeks of FDC treatment
The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS])
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: • 0. No urgency; • 1. Mild urgency; • 2. Moderate urgency; • 3. Severe urgency; • 4. Urgency incontinence TUS/TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.
Baseline and up to 52 weeks of FDC treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Time Frame: Baseline and up to 52 weeks of FDC treatment
A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition
Time Frame: Baseline and up to 52 weeks of FDC treatment
A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition
Time Frame: Baseline and up to 52 weeks of FDC treatment
A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours
Time Frame: Baseline and up to 52 weeks of FDC treatment
An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Time Frame: Baseline and up to 52 weeks of FDC treatment
An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Time Frame: Baseline and up to 52 weeks of FDC treatment
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours
Time Frame: Baseline and up to 52 weeks of FDC treatment
A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours
Time Frame: Baseline and up to 52 weeks of FDC treatment
The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Voiding Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Storage Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency,urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in IPSS Quality of Life (QoL) Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Symptom Bother Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The Symptom Bother portion consists of an 8-item scale scored from 1 to 6.The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from baseline indicates an improvement.
Baseline and up to 52 weeks of FDC treatment
Number of OAB-q Responders Based on Health-related Quality of Life: Total Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Individual IPSS Scores
Time Frame: Baseline and up to 52 weeks of FDC treatment
The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: • Incomplete emptying of the bladder • Intermittency • Weak stream • Hesitancy • Frequency • Urgency • Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Coping Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Concern Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Sleep Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Social Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in Health-related Quality of Life (HRQoL) Subscale: Total Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: • coping • concern • sleep • social interaction Total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Mobility Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Self-care Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).
Baseline and up to 52 weeks of FDC treatment
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score
Time Frame: Baseline and up to 52 weeks of FDC treatment
The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: • mobility • self-care • usual activity • pain/discomfort • anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).
Baseline and up to 52 weeks of FDC treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Europe B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Use Central Contact, Astellas Pharma Global Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 905-CL-057
  • 2008-001212-20 (EudraCT Number: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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