Trial · NCT01021332
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
NCT01021332, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2016-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms. Trials, record NCT01021332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021332
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
- NCT number
- NCT01021332
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,067 participants, actual
- Lead sponsor
- Astellas Pharma Europe B.V.
- Conditions
- Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
- Interventions
- tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg), tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
- First posted
- 2009-11-26
- Last updated
- 2024-12-03
- Other registries' IDs
- eudract:2008-001212-20
- Results first posted
- 2016-01-22
- Limitations and caveats
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | 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). |
| Primary | Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | 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. |
| Primary | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Baseline and up to 52 weeks of FDC treatment | Qmax during a micturition (urination) was recorded using uroflowmetry. |
| Primary | Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | Baseline and up to 52 weeks of FDC treatment | Qmean during a micturition (urination) was recorded using uroflowmetry. |
| Primary | Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | 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). |
| Primary | Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS) (Previously Known as Total Urgency Score [TUS]) | 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. |
| Secondary | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | 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. |
| Secondary | Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | 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. |
| Secondary | Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | 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. |
| Secondary | Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | 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. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) | 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 analysis set-participants who received at least 1 dose of the FDC tamsulosin/solifenacin 0.4 mg/6 mg or 0.4 mg/9 mg during the open-label treatment period and had any data reported after the first dose of the FDC during the open-label treatment period | participants | NUMBER |
| PRIMARY | Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | Baseline and up to 52 weeks of FDC treatment | SAF population with at least one baseline and one post-baseline PVR volume measured. | ml | MEAN |
| PRIMARY | Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Baseline and up to 52 weeks of FDC treatment | SAF population with at least one baseine and one post-baseline micturition episode. | ml/s | MEAN |
| PRIMARY | Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | Baseline and up to 52 weeks of FDC treatment | SAF population with at least one baseline and one post-baseline micturition episode. | ml/s | MEAN |
| PRIMARY | Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | Baseline and up to 52 weeks of FDC treatment | Full Analysis Set (FAS)-participants who took at least 1 dose of the FDC during the open-label study, had a total IPSS or TUS at baseline and had at least one total IPSS or TUS after first dose of the FDC in Study 905-CL-057. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | micturitions | MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | Baseline and up to 52 weeks of FDC treatment | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | ml | MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition | Baseline and up to 52 weeks of FDC treatment | FAS population with data available at both baseline and end of treatment. LOCF imputation was used. | ml | MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | FAS population with at least 1 urgency episode at baseline. LOCF imputation was used. | urgency episodes | MEAN |
| SECONDARY | Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours | Baseline and up to 52 weeks of FDC treatment | FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used. | urgency incontinence episodes | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group115
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) | Total Group | Participants With Treatment-Emergent Adverse Event | 499 | participants | |
| Number of Participants With Adverse Events (AEs) | Total Group | Drug-related AEs | 255 | participants | |
| Number of Participants With Adverse Events (AEs) | Total Group | Drug-related SAEs | 12 | participants | |
| Number of Participants With Adverse Events (AEs) | Total Group | Any TEAE causing discontinuation of study drug. | 69 | participants | |
| Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume | Total Group | 10.7 | Standard Deviation 49.28 | ml | |
| Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax) | Total Group | 4.54 | Standard Deviation 5.927 | ml/s | |
| Change From Baseline to End of Treatment in Average Flow Rate (Qmean) | Total Group | 2.05 | Standard Deviation 2.884 | ml/s | |
| Change From Baseline to End of Treatment in Total International Prostate Symptom Score (IPSS) | Total Group | -9.0 | Standard Deviation 5.69 | units on a scale | |
| Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours | Total Group | -2.5 | Standard Deviation 2.37 | micturitions | |
| Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition | Total Group | 39.0 | Standard Deviation 47.32 | ml |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Group | 1,066 | |
| Overall Study | Safety Analysis Set (SAF) | Total Group | 1,066 | |
| Overall Study | Full Analysis Set (FAS) | Total Group | 1,009 | |
| Overall Study | COMPLETED | Total Group | 960 | |
| Overall Study | NOT COMPLETED | Total Group | 106 |
Source ClinicalTrials.gov
Adverse events71
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Total Group | 55 | 1,066 | 61 |
| other | Dry Mouth | Gastrointestinal disorders | Total Group | 132 | 1,066 | 138 |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 2 | 1,066 | |
| serious | Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 2 | 1,066 | |
| serious | Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 2 | 1,066 | |
| serious | Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 1 | 1,066 | |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 1 | 1,066 | |
| serious | Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 1 | 1,066 | |
| serious | Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 1 | 1,066 | |
| serious | Neuroendocrine tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Total Group | 1 | 1,066 |
1 to 10 of 71Source ClinicalTrials.gov
See all 71 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Group | ||
| Total, other adverse events | Total Group | 180 | 1,066 |
| Total, serious adverse events | Total Group | 64 | 1,066 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01021332
GET https://conductscience.org/api/trials/v1/NCT01021332/registered?page=2