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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Matching Placebo
- DRUG Solabegron modified release tablets, low dose
- DRUG Solabegron modified release tablets, high dose
Study Locations (20)
California
- Velicept Investigative Site - Lincoln — Lincoln
- Velicept Investigative Site - North Hollywood — North Hollywood
- Velicept Investigative Site - Sacramento — Sacramento
- Velicept Investigative Site - San Diego — San Diego
- Velicept Investigative Site - San Diego — San Diego
- Velicept Investigative Site - Spring Valley — Spring Valley
- Velicept Investigative Site - Upland — Upland
Alabama
- Velicept Investigative Site - Birmingham — Birmingham
- Velicept Investigative Site - Birmingham — Birmingham
- Velicept Investigative Site - Guntersville — Guntersville
- Velicept Investigative Site - Saraland — Saraland
Florida
- Velicept Investigative Site - Aventura — Aventura
- Velicept Investigative Site - Doral(2) — Doral
- Velicept Investigative Site - Doral — Doral
- Velicept Investigative Site - Edgewater — Edgewater
Arizona
- Velicept Investigative Site - Tucson — Tucson
- Velicept Investigative Site - Tucson — Tucson
Colorado
- Velicept Investigative Site - Aurora — Aurora
- Velicept Investigative Site - Englewood — Englewood
Connecticut
- Velicept Investigative Site - New London — New London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,413 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2019-05-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03594058
The ClinicalTrials.gov registry entry for NCT03594058 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Velicept Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 3 interventions — of which Matching Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03594058 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Alabama, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03594058 about?
NCT03594058 is a clinical study titled "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)". 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 fem...
What is the current status of trial NCT03594058?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,413 participants. The study started on 2018-07-09. Estimated completion is 2019-05-02.
What conditions does trial NCT03594058 study?
This clinical trial studies the following conditions: Overactive Bladder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03594058?
The interventions under investigation include: Matching Placebo (DRUG), Solabegron modified release tablets, low dose (DRUG), Solabegron modified release tablets, high dose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03594058?
This trial is sponsored by Velicept Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03594058 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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