A Clinical Study to Assess the Effectiveness and Side effects of Mirabegron Plus Solifenacin in Patients with Urinary Frequency and Urgency

A Phase III, Multi-Center, Double Blind, Comparative, Active-Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Mirabegron Plus Solifenacin in Indian Adult Patients with Symptoms of Overactive Bladder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030395

Enrollment

336

Registered

2021-01-12

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N328- Other specified disorders of bladder

Interventions

Intervention1: Group A: Mirabegron 25 mg Plus Solifenacin 5 mg Fixed dose combination Tablet Group B: Mirabegron 50 mg Plus Solifenacin 5 mg Fixed dose combination Tablet: One Tablet, after breakfast,

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult male or female patients with age of 18 to 65 years 2. Patients who are treatment naÃ¯ve or received prior anticholinergics medication 3. Patients with an average frequency of micturition of 8 or more times per 24-hour 4. Patients with an average episode of urgency with or without incontinence of one or more times per 24-hours period

Exclusion criteria

Exclusion criteria: 1. Hypersensitive history to mirabegron, solifenacin, other antimuscarinic, other beta-adrenoreceptor (Ã?-AR) agonists 2. Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and/or other urological disorder 3. Patients with stress urinary incontinence as a predominant symptom 4. Patients with bladder outflow obstruction, urinary tract infection, urinary stones, and/or interstitial cystitis or chronic inflammation due to bladder pain syndrome or with a history of recurrent urinary tract infections 5. Patients with indwelling catheter or practicing intermittent self-catheterization 6. Patients with history of diabetic neuropathy 7. Currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Change in mean number of micturitions per 24 hoursTimepoint: Baseline and End of Week 12	—

Secondary

Measure	Time frame
Change in mean number of incontinence episodes per 24 hours Timepoint: Baseline, Week 4, Week 8 and Week 12;Change in mean number of micturitions per 24 hoursTimepoint: Baseline, Week 4 and Week 8;Change in mean number of urgency episodes per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Change in OABSS scoreTimepoint: Baseline, Week 4, Week 8 and Week 12;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: All Visits	—

Measure

Time frame

Change in mean number of incontinence episodes per 24 hours Timepoint: Baseline, Week 4, Week 8 and Week 12;Change in mean number of micturitions per 24 hoursTimepoint: Baseline, Week 4 and Week 8;Change in mean number of urgency episodes per 24 hoursTimepoint: Baseline, Week 4, Week 8 and Week 12;Change in OABSS scoreTimepoint: Baseline, Week 4, Week 8 and Week 12;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: All Visits

—

Countries

India

Contacts

Public ContactDr Shubhadeep Sinha

Hetero Labs Limited

sreenivasa.chary@heterodrugs.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026