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

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ClinicalTrials.gov Identifier: NCT00874120
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : July 5, 2010
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Conditions Blood Pressure
Human Experimentation
Interventions Drug: Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg
Drug: Placebo
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phenylephrine Followed by Placebo Placebo Followed by Phenylephrine
Hide Arm/Group Description Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
Period Title: First Intervention
Started 58 58
Completed 52 56
Not Completed 6 2
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             2             0
Lost to Follow-up             0             1
Protocol Violation             3             0
positive drug test             1             0
Period Title: Wash-out Period
Started 52 56
Completed 52 56
Not Completed 0 0
Period Title: Second Intervention
Started 52 56
Completed 50 56
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Protocol Violation             1             0
Arm/Group Title Phenylephrine Followed by Placebo Placebo Followed by Phenylephrine Total
Hide Arm/Group Description Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 58 58 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 58 participants 116 participants
29.4  (10.14) 29.0  (10.99) 29.2  (10.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Female
29
  50.0%
26
  44.8%
55
  47.4%
Male
29
  50.0%
32
  55.2%
61
  52.6%
1.Primary Outcome
Title Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).
Hide Description Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.
Time Frame 24 hours after final dose of each 7-day treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population included 100 participants who completed both treatment periods and have 24-hour Ambulatory Blood Pressure Monitoring (ABPM) data for SBP measurements for each study drug, 46 participants who received phenylephrine followed by placebo and 54 participants who received placebo followed by phenylephrine.
Arm/Group Title Phenylephrine Placebo
Hide Arm/Group Description:
Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
Placebo twice daily for 7 days
Overall Number of Participants Analyzed 100 100
Mean (Standard Deviation)
Unit of Measure: mmHg
118.3  (9.24) 118.6  (9.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phenylephrine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5480
Comments P-value is based on an ANOVA model including sequence, subject within sequence, period and treatment as factors.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter residual error term from the ANOVA
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-2.0 to 1.1
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Intent-to-treat population. Participants who received at least one dose of study medication were included in the safety population.
 
Arm/Group Title Phenylephrine Placebo
Hide Arm/Group Description Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days Placebo twice daily for 7 days
All-Cause Mortality
Phenylephrine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phenylephrine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/111 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phenylephrine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/111 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor reserves all publication and presentation rights.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00874120     History of Changes
Other Study ID Numbers: 18121
CL2007-07
P07529 ( Other Identifier: Merck )
First Submitted: April 1, 2009
First Posted: April 2, 2009
Results First Submitted: June 2, 2010
Results First Posted: July 5, 2010
Last Update Posted: March 11, 2015