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

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ClinicalTrials.gov Identifier: NCT01004705
Recruitment Status : Terminated
First Posted : October 30, 2009
Results First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Elevated LDL Cholesterol
Interventions Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),
Drug: Simvastatin
Enrollment 36
Recruitment Details 126 subjects were screened, 47 met eligibility requirements and 44 entered the run-in period.
Pre-assignment Details  
Arm/Group Title Pre-randomization Run-In Combination Pill Then Simvastatin Simvastatin Then Combination Pill
Hide Arm/Group Description Screening period with ramipril 2.5 mg 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 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.
Period Title: Run-In
Started 44 0 0
Completed 36 0 0
Not Completed 8 0 0
Period Title: Period 1 (12 Weeks)
Started 0 18 18
Completed 0 13 13
Not Completed 0 5 5
Period Title: Washout Period (6 Weeks)
Started 0 13 13
Completed 0 13 13
Not Completed 0 0 0
Period Title: Period 2 (12 Weeks)
Started 0 13 13
Completed 0 13 9
Not Completed 0 0 4
Arm/Group Title Randomized Patients
Hide Arm/Group Description All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
44.6  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
14
  38.9%
Male
22
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
1.Primary Outcome
Title The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.
Hide Description 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.
Time Frame Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population
Arm/Group Title Combination Pill Simvastatin
Hide Arm/Group Description:
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.
Once daily oral dose of 40 mg simvastatin for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mg/dL
-34.24  (27.103) -27.95  (32.597)
2.Secondary Outcome
Title The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.
Hide Description 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.
Time Frame Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol population
Arm/Group Title Combination Pill Simvastatin
Hide Arm/Group Description:
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.
Once daily oral dose of 40 mg simvastatin for 12 weeks
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mg/dL
-36.81  (28.715) -29.81  (38.407)
Time Frame 36 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pre-randomization Run-In Combination Pill Simvastatin
Hide Arm/Group Description Screening period with ramipril 2.5 mg 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 Once daily oral dose of 40 mg simvastatin for 12 weeks
All-Cause Mortality
Pre-randomization Run-In Combination Pill Simvastatin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pre-randomization Run-In Combination Pill Simvastatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/31 (0.00%)      0/31 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pre-randomization Run-In Combination Pill Simvastatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      1/31 (3.23%)      2/31 (6.45%)    
Infections and infestations       
Upper respiratory tract infection  1  0/44 (0.00%)  0 1/31 (3.23%)  1 2/31 (6.45%)  2
Investigations       
Blood phosphokinase creatine increased  1  0/44 (0.00%)  0 1/31 (3.23%)  1 2/31 (6.45%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Early termination leading to small numbers of subjects analyzed.
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.
Publication must be agreed upon with the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Natalia Oudovenko
Organization: Ferrer Internacional S.A.
Phone: +34 93 509 32 82
EMail: noudovenko-research@ferrergrupo.com
Layout table for additonal information
Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT01004705     History of Changes
Other Study ID Numbers: P-080647-01
First Submitted: October 23, 2009
First Posted: October 30, 2009
Results First Submitted: June 1, 2012
Results First Posted: August 31, 2012
Last Update Posted: August 31, 2012