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Effect of Niacin in the Lipoprotein (a) Concentration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01321034
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
Hospital Miguel Servet
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud

Tracking Information
First Submitted Date  ICMJE March 22, 2011
First Posted Date  ICMJE March 23, 2011
Last Update Posted Date January 10, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant in subjects with normal Lp(a) (<30 mg/dL), high Lp(a) (30-60 mg/dL) and very high Lp(a) (>60 mg/dL g/40 mg day of Niacin/Laropiprant [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the apo(a) gene. [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Niacin in the Lipoprotein (a) Concentration
Official Title  ICMJE Effect of Niacin in the Lipoprotein (a) Concentration With Regard to Apolipoprotein (a) Size and Baseline Lipoprotein (a) Concentration.
Brief Summary

Objectives.

  • To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant in subjects with normal Lp(a) (< 30 mg/dL), high Lp(a) (30-60 mg/dL) and very high Lp(a) (> 60 mg/dL).
  • To evaluate the absolute and relative Lp(a) lowering effect of 1g/20 mg and 2 g/40 mg day of Niacin/Laropiprant depending on the number of kringle IV-2 repeated copies on the apo(a) gene. 2.1.1 Hypotheses.
  • The Lp(a) lowering effect of niacin is dependent of the pre-treatment Lp(a) concentration, with higher absolute and relative reduction in Lp(a) in subjects with hyperlipoproteinemia(a).
  • Lp(a) size, throughout modifying hepatic synthesis of apo(a), is a major factor related to the lowering effect variability of niacin in human.
Detailed Description

Open-label 12-week study, 1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day. Subjects with normal Lp(a) will be use as comparative group for the other two groups, so no placebo group is required is this study.

Subjects: volunteers from the Lipid Clinic of Hospital Universitario Miguel Servet of Zaragoza, Spain. Subjects were selected according to their previously determined Lp(a)concentration. All volunteers before any study procedure will have to give written inform consent to a protocol previously approved for the Ethical Committees of our institutions.

Biochemical determinations: lipids: total cholesterol and triglycerides; lipoproteins: HDL-cholesterol, Lp(a); apolipoproteins: Apo A1 and apo B and safety biochemical parameters (glucose, uric acid, creatinine, liver and muscle enzymes will be measured at baseline and at the end of the two treatment periods (weeks 4 and 8).

An adverse experience questionnaire will be done in each visit. Genetic analysis: apo(a) genetic polymorphism responsible of the Lp(a) size variability will be analyzed by a PCR-based methodology (Lanktree et al. J Lipid Res 2009; 50: 768-72 ).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE Drug: Niacin/Laropiprant
1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.
Study Arms  ICMJE Niacin/Laropiprant
Subjects with normal Lp(a) will be use as comparative group for the other two groups, so no placebo group is required is this study
Intervention: Drug: Niacin/Laropiprant
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2011)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age >18 and < 80 years
  2. LDL cholesterol between 70 and 190 mg/dL
  3. Triglycerides < 500 mg/dL
  4. At least 2 Lp(a) determinations previous to the beginning of the study without differences >20% or > 20 mg/dL.
  5. No lipid lowering therapy or on stable doses in the last 3 months

Exclusion Criteria:

  1. Liver disease or liver enzymes >2 times higher than reference values
  2. Creatinine > 2 mg/dL
  3. Active peptic ulcer
  4. Clinical gout in the last year
  5. Uncontrolled diabetes (HbA1c >8%)
  6. Enrolment in other drug clinical trial in the previous 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01321034
Other Study ID Numbers  ICMJE EudraCT 2010-022258-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fernando Civeira, Instituto Aragones de Ciencias de la Salud
Original Responsible Party Fernando Civeira/Chief Lipid Clinic, Hospital Universitario Miguel Servet
Current Study Sponsor  ICMJE Instituto Aragones de Ciencias de la Salud
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hospital Miguel Servet
Investigators  ICMJE
Principal Investigator: Fernando Civeira, MD Hospital Miguel Servet
PRS Account Instituto Aragones de Ciencias de la Salud
Verification Date January 2013

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