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

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Ferrer Internacional S.A.

ClinicalTrials.gov Identifier:

NCT01004705

First received: October 23, 2009

Last updated: July 31, 2012

Last verified: July 2012

History of Changes

Results First Received: June 1, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Elevated LDL Cholesterol
Interventions:	Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), Drug: Simvastatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
126 subjects were screened, 47 met eligibility requirements and 44 entered the run-in period.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow for 4 periods

Period 1: Run-In

	Pre-randomization Run-In	Combination Pill Then Simvastatin	Simvastatin Then Combination Pill
STARTED	44	0	0
COMPLETED	36	0	0
NOT COMPLETED	8	0	0

Period 2: Period 1 (12 Weeks)

	Combination Pill Then Simvastatin	Simvastatin Then Combination Pill
STARTED	18	18
COMPLETED	13	13
NOT COMPLETED	5	5

Period 3: Washout Period (6 Weeks)

	Combination Pill Then Simvastatin	Simvastatin Then Combination Pill
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Period 4: Period 2 (12 Weeks)

	Combination Pill Then Simvastatin	Simvastatin Then Combination Pill
STARTED	13	13
COMPLETED	13	9
NOT COMPLETED	0	4

Baseline Characteristics

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Reporting Groups

	Description
Randomized Patients	All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)

Baseline Measures

	Randomized Patients
Number of Participants [units: participants]	36
Age [units: years] Mean ± Standard Deviation	44.6 ± 11.44
Gender [units: participants]
Female	14
Male	22
Region of Enrollment [units: participants]
United States	36

Outcome Measures

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1. Primary:

The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period. [ Time Frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 ]

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2. Secondary:

The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period. [ Time Frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Publication must be agreed upon with the sponsor.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed.

Results Point of Contact:

Name/Title: Natalia Oudovenko
Organization: Ferrer Internacional S.A.
phone: +34 93 509 32 82
e-mail: noudovenko-research@ferrergrupo.com

No publications provided

Responsible Party:	Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:	NCT01004705 History of Changes
Other Study ID Numbers:	P-080647-01
Study First Received:	October 23, 2009
Results First Received:	June 1, 2012
Last Updated:	July 31, 2012
Health Authority:	United States: Food and Drug Administration

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