NCT00463541 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Capo' JP Jr, Laramée C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S
Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial. Int J Clin Pract. 2008 Jan;62(1):39-46. Epub 2007 Nov 23.
Garely AD, Kaufman JM, Sand PK, Smith N, Andoh M
Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006 Nov;28(11):1935-46.
Garely AD, Lucente V, Vapnek J, Smith N
Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother. 2007 Mar;41(3):391-8. Epub 2007 Mar 6.
Mallett V, Burks D, Garely AD, Smith N
Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin. 2007 Apr;23(4):821-31.
Sand PK, Steers WD, Dmochowski R, Andoh M, Forero-Schwanhaeuser S
Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):667-75. doi: 10.1007/s00192-009-0840-y. Epub 2009 Mar 10.

An Open-label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial

Details for clinical trial NCT00463541

Clinical trial NCT00463541 - References