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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.

Tracking Information
First Submitted Date  ICMJE October 23, 2009
First Posted Date  ICMJE October 30, 2009
Results First Submitted Date  ICMJE June 1, 2012
Results First Posted Date  ICMJE August 31, 2012
Last Update Posted Date August 31, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
Difference in LDL cholesterol levels between the basal and the final visit of each treatment period. [ Time Frame: Day 84 (treatment period 1) and Day 210 (treatment period 2) ]
Change History Complete list of historical versions of study NCT01004705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
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 ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2009)
  • Difference in VLDL cholesterol levels between the basal and the final visit of each treatment period. [ Time Frame: Day 84 (treatment period 1) and Day 210 (treatment period 2) ]
  • Difference in HDL cholesterol levels between the basal and the final visit of each treatment period. [ Time Frame: Day 84 (treatment period 1) and Day 210 (treatment period 2) ]
  • Difference in total cholesterol levels between the basal and the final visit of each treatment period. [ Time Frame: Day 84 (treatment period 1) and Day 210 (treatment period 2) ]
  • Difference in triglyceride levels between the basal and the final visit of each treatment period. [ Time Frame: Day 84 (treatment period 1) and Day 210 (treatment period 2) ]
  • To evaluate the safety and tolerability of dosing with the cardiovascular fixed dose combination pill and the safety and tolerability of dosing with simvastatin alone. [ Time Frame: During the whole study period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol
Official Title  ICMJE Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Study of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin, and Ramipril in Subjects With Elevated LDL Cholesterol
Brief Summary This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Elevated LDL Cholesterol
Intervention  ICMJE
  • Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),
    A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.
  • Drug: Simvastatin
    A once daily oral dose of simvastatin for 12 weeks.
Study Arms  ICMJE
  • Experimental: Fixed Dose Combination Pill
    Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril)
    Intervention: Drug: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril),
  • Active Comparator: Simvastatin
    Once daily oral dose of Simvastatin 40 mg
    Intervention: Drug: Simvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 11, 2012)
36
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2009)
60
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects ≥18 years of age
  • Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
  • Provide written informed consent.

Exclusion Criteria:

  • Subjects with a medical condition requiring chronic pharmacological treatment
  • On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
  • On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
  • Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
  • Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
  • Presence of secondary dyslipidemia.
  • Previous use of cholesterol lowering medication.
  • Previous coronary artery bypass graft (CABG).
  • Previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
  • Presence of severe congestive heart failure (New York Heart Classification [NYHC] III IV).
  • Presence of untreated or uncontrolled thyroid disease.
  • Past or current medical history of asthma or aspirin induced asthma
  • Previous hypersensitivity to ACE inhibitors (eg angioedema or cough).
  • Previous hypersensitivity to ARBs.
  • History of unstable angina.
  • Serum creatinine >2 mg/dL.
  • Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
  • Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
  • Total bilirubin ≥1.5 x ULN.
  • Serum triglyceride concentration ≥400 mg/dL.
  • Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
  • Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
  • Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
  • Presence of mental illness limiting the capacity for self-care.
  • Presence of major systemic illnesses: renal disease, liver disease, neurological or psychiatric disease.
  • Participation, in the 30 days preceding enrolment into the study, in any other clinical study in which investigational or marketed drugs were employed.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004705
Other Study ID Numbers  ICMJE P-080647-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferrer Internacional S.A.
Study Sponsor  ICMJE Ferrer Internacional S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ferrer Internacional S.A.
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP