Trial Outcomes & Findings for A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol (NCT NCT01004705)

Last Updated: 2012-08-31

Results Overview

Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2

Results posted on

2012-08-31

Participant Flow

126 subjects were screened, 47 met eligibility requirements and 44 entered the run-in period.

Participant milestones

Participant milestones
Measure	Pre-randomization Run-In Screening period with ramipril 2.5 mg	Combination Pill Then Simvastatin After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks	Simvastatin Then Combination Pill After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks.
Run-In STARTED	44	0	0
Run-In COMPLETED	36	0	0
Run-In NOT COMPLETED	8	0	0
Period 1 (12 Weeks) STARTED	0	18	18
Period 1 (12 Weeks) COMPLETED	0	13	13
Period 1 (12 Weeks) NOT COMPLETED	0	5	5
Washout Period (6 Weeks) STARTED	0	13	13
Washout Period (6 Weeks) COMPLETED	0	13	13
Washout Period (6 Weeks) NOT COMPLETED	0	0	0
Period 2 (12 Weeks) STARTED	0	13	13
Period 2 (12 Weeks) COMPLETED	0	13	9
Period 2 (12 Weeks) NOT COMPLETED	0	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Patients n=36 Participants All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
Age Continuous	44.6 years STANDARD_DEVIATION 11.44 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2

Population: Per Protocol population

Outcome measures

Outcome measures
Measure	Combination Pill n=21 Participants Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.	Simvastatin n=21 Participants Once daily oral dose of 40 mg simvastatin for 12 weeks
The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.	-34.24 mg/dL Standard Deviation 27.103	-27.95 mg/dL Standard Deviation 32.597

SECONDARY outcome

Timeframe: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2

Population: Per Protocol population

Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.

Outcome measures

Outcome measures
Measure	Combination Pill n=21 Participants Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.	Simvastatin n=21 Participants Once daily oral dose of 40 mg simvastatin for 12 weeks
The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.	-36.81 mg/dL Standard Deviation 28.715	-29.81 mg/dL Standard Deviation 38.407

Adverse Events

Pre-randomization Run-In

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination Pill

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Simvastatin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pre-randomization Run-In n=44 participants at risk Screening period with ramipril 2.5 mg	Combination Pill n=31 participants at risk Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks	Simvastatin n=31 participants at risk Once daily oral dose of 40 mg simvastatin for 12 weeks
Investigations Blood phosphokinase creatine increased	0.00% 0/44 • 36 weeks	3.2% 1/31 • Number of events 1 • 36 weeks	6.5% 2/31 • Number of events 2 • 36 weeks
Infections and infestations Upper respiratory tract infection	0.00% 0/44 • 36 weeks	3.2% 1/31 • Number of events 1 • 36 weeks	6.5% 2/31 • Number of events 2 • 36 weeks

Additional Information

Natalia Oudovenko

Ferrer Internacional S.A.

Phone: +34 93 509 32 82

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication must be agreed upon with the sponsor.
Publication restrictions are in place

Restriction type: OTHER