NCT00323635 - 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)

Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP
The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. Review.
Brooks JO 3rd, Friedman L, Bliwise DL, Yesavage JA
Use of the wrist actigraph to study insomnia in older adults. Sleep. 1993 Feb;16(2):151-5.
Roehrs T, Merlotti L, Petrucelli N, Stepanski E, Roth T
Experimental sleep fragmentation. Sleep. 1994 Aug;17(5):438-43.
Shaver JL, Paulsen VM
Sleep, psychological distress, and somatic symptoms in perimenopausal women. Fam Pract Res J. 1993 Dec;13(4):373-84.

A Parallel, Double-blind Comparison of Tolterodine vs. Placebo Treatments for Nocturia in Postmenopausal Women.

Clinical trial NCT00323635 - References