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

NCT00874120 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2015-03-11

Study results available
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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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-02-28
Completion
2009-02-28

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Entities

Drugs
Companies

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 NCT00874120 on ClinicalTrials.gov