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A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)

NCT03594058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1413

Last updated 2020-03-02

No results posted yet for this study

Summary

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.

Conditions

Interventions

DRUG

Solabegron modified release tablets, low dose

Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

DRUG

Solabegron modified release tablets, high dose

Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

DRUG

Matching Placebo

Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

Sponsors & Collaborators

  • Velicept Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2019-04-29
Completion
2019-05-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594058 on ClinicalTrials.gov