NCT00874120

Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED)

Randomized, Placebo-Controlled, Double-Blind, Two-Way Crossover Study to Evaluate the Effects of Phenylephrine HCl Extended-Release Tablets 30 mg Compared to Placebo on Ambulatory Blood Pressure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Randomized, placebo-controlled double-blind, crossover design study; 116 subjects randomized on Day 1 to obtain 98 completed subjects. Study will be composed of a 7-day period of therapy with randomized active or placebo treatment with a subsequent 6-8 day washout period, followed by a second 7-day period of double-blind therapy with the other agent. Ambulatory blood pressure measurement will be performed beginning on Day 7 of each treatment period following administration of the study drug.

Conditions

• Blood Pressure
• Human Experimentation

Interventions

Type	Name	Description
DRUG	Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg	Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days.
DRUG	Placebo	Placebo taken twice daily (12 hours apart) for 7 days.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2009-04-02
• Last updated: 2015-03-11
• Results posted: 2010-07-05