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This is a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder (SYNERGY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01972841
First received: October 25, 2013
Last updated: October 21, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Condition Intervention Phase
Urinary Bladder Overactive
Urinary Bladder Diseases\Urologic Diseases
Overactive Bladder
Urgency Incontinence
Drug: Solifenacin Succinate
Drug: Mirabegron
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in mean number of incontinence episodes per 24 hours at End of Treatment (EoT) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of micturitions per 24 hours at EoT [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in mean volume voided per micturition at EoT [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Symptom Bother as assessed by Overactive Bladder Questionnaire (OAB-q) at EoT [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Subject assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS) at EoT [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Number of incontinence episodes during the 7-day observation period prior to week 4, 8, 12 and EoT and changes from baseline [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of incontinence episodes per 24 hours at secondary time points (after 4, 8 and 12 weeks of treatment) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of micturitions per 24 hours at secondary time points (after 4, 8 and 12 weeks of treatment) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean volume voided at secondary time points (after 4, 8 and 12 weeks of treatment) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Number of urgency incontinence episodes during the 7-day observation period prior to week 4, 8, 12 and EoT and changes from baseline [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency incontinence episodes per 24 hours (Week 4, 8, 12, and EoT) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of urgency episodes (grade 3 and/or 4)/24 hours (PPIUS scale) (Week 4, 8, 12, and EoT) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Number of nocturia episodes during the 7-day observation period prior to Week 4, 8, 12, and EoT and changes from baseline [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of nocturia episodes per 24 hours(Week 4, 8, 12, and EoT) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Number of pads used during the 7-day observation period prior to Week 4, 8, 12, and EoT and changes from baseline [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of pads used per 24 hours (Week 4, 8, 12, and EoT) [ Time Frame: Baseline & 12 weeks ] [ Designated as safety issue: No ]
  • Number of incontinence-free days during the 7-day diary period (Week 4, 8, 12, and EoT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of days with less than 8 micturitions during the 7-day diary period (Week 4, 8, 12, and EoT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of incontinence-free days with less than 8 micturitions per day during the 7-day diary period (Week 4, 8, 12, and EoT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 6991
Study Start Date: November 2013
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Solifenacin succinate + Mirabegron lower dose
Oral
Drug: Solifenacin Succinate
Oral tablet
Other Names:
  • Vesikur
  • Vesitrim
  • YM905
  • Vesicare
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq
Experimental: 2: Solifenacin succinate + Mirabegron higher dose
Oral
Drug: Solifenacin Succinate
Oral tablet
Other Names:
  • Vesikur
  • Vesitrim
  • YM905
  • Vesicare
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq
Placebo Comparator: 3: Placebo
Oral
Drug: Placebo
Oral tablet
Active Comparator: 4: Solifenacin succinate
Oral
Drug: Solifenacin Succinate
Oral tablet
Other Names:
  • Vesikur
  • Vesitrim
  • YM905
  • Vesicare
Active Comparator: 5: Mirabegron lower dose
Oral
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq
Active Comparator: 6: Mirabegron higher dose
Oral
Drug: Mirabegron
Oral tablet
Other Names:
  • YM178
  • Betmiga
  • Betanis
  • Myrbetriq

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
  • Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria:

  • Subject has significant PVR volume (> 150 mL);
  • Subject has a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component can be inferred when autonomic functions are affected, including heart rate, blood pressure, perspiration and digestion.
  • Subject has an indwelling catheter or practices intermittent self catheterization.
  • Subject has chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
  • Subject has received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
  • Subject has moderate to severe hepatic impairment
  • Subject has severe renal impairment
  • Subject has a clinically significant abnormal ECG
  • Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
  • Subject has an average QTcF interval > 450 ms for males or > 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
  • Subject has severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972841

  Show 432 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Director: Medical Director Astellas Pharma Europe B.V.
  More Information

Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01972841     History of Changes
Other Study ID Numbers: 178-CL-101  2012-005735-91  U1111-1153-9095 
Study First Received: October 25, 2013
Last Updated: October 21, 2016
Health Authority: Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Norway: Norwegian Medicines Agency
Slovenia: Slovenian Agency for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Taiwan: Ministry of Health and Welfare
China: Food and Drug Administration
Romania: National Agency for Medicines and Medical Devices
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
South Africa: Medicines Control Council
Denmark: Danish Health and Medicines Authority
Slovakia: State Institute for Drug Control
Peru: Instituto Nacional de Salud
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Ukraine: Ministry of Health
Mexico: Ministry of Health
Turkey: Ministry of Health
Finland: Finnish Medicines Agency
Hong Kong: Department of Health
Brazil: National Health Surveillance Agency
New Zealand: Medsafe
Estonia: The State Agency of Medicine
Malaysia: Ministry of Health
Lithuania: State Medicine Control Agency - Ministry of Health
United States: Food and Drug Administration
Spain: Ministry of Health and Consumption
Korea: Ministry of Food and Drug Safety
Latvia: State Agency of Medicines
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
Thailand: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Sweden: Medical Products Agency
Argentina: Ministry of Health
Philippines : Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Combination Therapy
Mirabegron
Overactive Bladder
Urgency
Urinary Incontinence
Nocturia
Solifenacin Succinate

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mirabegron
Solifenacin Succinate
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on December 08, 2016