Trial Outcomes & Findings for Safety Study Comparing Phenylephrine HCL Extended Release Tablets 30 mg and Placebo (Study CL2007-07)(P07529)(COMPLETED) (NCT NCT00874120)

Last Updated: 2015-03-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

116 participants

Primary outcome timeframe

24 hours after final dose of each 7-day treatment period.

Results posted on

2015-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Phenylephrine Followed by Placebo 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 Followed by Phenylephrine 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
First Intervention STARTED	58	58
First Intervention COMPLETED	52	56
First Intervention NOT COMPLETED	6	2
Wash-out Period STARTED	52	56
Wash-out Period COMPLETED	52	56
Wash-out Period NOT COMPLETED	0	0
Second Intervention STARTED	52	56
Second Intervention COMPLETED	50	56
Second Intervention NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phenylephrine Followed by Placebo 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 Followed by Phenylephrine 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
First Intervention Adverse Event	0	1
First Intervention Withdrawal by Subject	2	0
First Intervention Lost to Follow-up	0	1
First Intervention Protocol Violation	3	0
First Intervention positive drug test	1	0
Second Intervention Withdrawal by Subject	1	0
Second Intervention Protocol Violation	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenylephrine Followed by Placebo n=58 Participants 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 Followed by Phenylephrine n=58 Participants 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 n=116 Participants Total of all reporting groups
Age, Continuous	29.4 years STANDARD_DEVIATION 10.14 • n=93 Participants	29.0 years STANDARD_DEVIATION 10.99 • n=4 Participants	29.2 years STANDARD_DEVIATION 10.53 • n=27 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	26 Participants n=4 Participants	55 Participants n=27 Participants
Sex: Female, Male Male	29 Participants n=93 Participants	32 Participants n=4 Participants	61 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours after final dose of each 7-day treatment period.

Population: 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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=100 Participants Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days	Placebo n=100 Participants Placebo twice daily for 7 days
Average Systolic Blood Pressure (SBP) Readings for a 5-hour Range Around the Time of Maximum Concentration (Tmax).	118.3 mmHg Standard Deviation 9.24	118.6 mmHg Standard Deviation 9.38

Adverse Events

Phenylephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor reserves all publication and presentation rights.
Publication restrictions are in place

Restriction type: OTHER