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Efficacy of LCQ908 on Cardiovascular Risk (im)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01474434
First received: November 9, 2011
Last updated: May 30, 2014
Last verified: May 2014

November 9, 2011
May 30, 2014
March 2011
June 2014   (final data collection date for primary outcome measure)
  • Myocardial perfusion/coronary flow reserve (Part A and Part B of the study) [ Time Frame: Part A; Baseline, and on day 5 of each of the 2 treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days ] [ Designated as safety issue: No ]
  • Time to onset of angina (Part A and Part B) [ Time Frame: Part A; Baseline and on day 5 of each of the two treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days. ] [ Designated as safety issue: No ]
  • Time to onset of exercise-induced ischemia(Part A and Part B) [ Time Frame: Part A; Baseline and on day 5 of each of the two treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days. ] [ Designated as safety issue: No ]
  • Total exercise duration (Part A and Part B) [ Time Frame: Part A; Baseline and on day 5 of each of the two treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days. ] [ Designated as safety issue: No ]
  • Aortic plaque inflammation (Part B) [ Time Frame: Baseline and on treatment day 85 +/- 3 days ] [ Designated as safety issue: No ]
  • Myocardial perfusion [ Time Frame: Up to 5 days during each of 2 treatment periods ] [ Designated as safety issue: No ]
    Changes in blood flow to the myocardium (heart muscle) will be determined before and after treatment
  • Inflammation and myocardial perfusion [ Time Frame: Up to Day 85 days during treatment period ] [ Designated as safety issue: No ]
    Changes in inflammation as well as changes in blood flow to the myocardium (heart muscle) will be determined before and after treatment
Complete list of historical versions of study NCT01474434 on ClinicalTrials.gov Archive Site
  • Postprandial triglycerides in Part A [ Time Frame: Part A: Day 5 of each treatment period ] [ Designated as safety issue: No ]
  • Percentage of patients with adverse events (Part A and Part B) [ Time Frame: Part A: approximately 40 days, Part B: Up to 85 days + 30 days follow up ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of LCQ908: Plasma concentration [ Time Frame: Part A: Day 4 and day 5 of each treatment period; Part B: Day 15, 29, 43, 57 and 85. ] [ Designated as safety issue: No ]
  • Other related lipid parameters (Part A and Part B) [ Time Frame: Part A: Baseline, day 4 and day 5 of each treatment period. Part B; Baseline, day 15, day 43 and day 85. ] [ Designated as safety issue: No ]
  • Interleukin-6 (IL-6) level (Part A and Part B) [ Time Frame: Part A: Baseline, day 4 and day 5, of each treatment period. Part B; Baseline, day 15, day 43 and day 85 ] [ Designated as safety issue: No ]
  • Adiponectin level ( Part B) [ Time Frame: Part B; Baseline, day 15, day 43 and day 85 ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) level (Part A and Part B) [ Time Frame: Part A: Baseline, day 4 and day 5, of each treatment period. Part B; Baseline, day 15, day 43 and day 85 ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: Part A: Up to 5 days during each of two treatment periods; Part B: Up to 85 days during the treatment period ] [ Designated as safety issue: No ]
    The levels of lipids and related particles in the blood will be measured
  • Biological Markers [ Time Frame: Part A: Up to 5 days during each of two treatment periods; Part B: Up to 85 days during treatment period ] [ Designated as safety issue: No ]
    The level of biological markers of physiologic process in the blood will be measured
  • Safety and Tolerability [ Time Frame: Part A:Up to 5 days during each of two treatment periods; Part B: Up to 85 days during treatment period ] [ Designated as safety issue: Yes ]
    Safety and tolerability including percentage of adverse events, laboratory analysis, impact on vital signs (blood pressure and pulse rate) and impact on ECGs will be assessed.
  • Levels of the study drug in the blood [ Time Frame: Part A: Up to 5 days during each of two treatment periods - daily; Part B: Up to 85 days during treatment period ] [ Designated as safety issue: No ]
    The level of the study drug in the blood will be measured at set points after the drug has been taken.
Not Provided
Not Provided
 
Efficacy of LCQ908 on Cardiovascular Risk
A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of LCQ908 on Cardiovascular Risk

This is a study designed to evaluate the potential for the LCQ908 to impact cardiovascular risk.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Hypertriglyceridemia
  • Drug: LCQ908
    In Part A of the study subjects will be randomly assigned to one of two treatment sequences; 1) LCQ908 treatment, followed by washout period, followed by placebo or 2) placebo, followed by a washout period, followed by LCQ908 treatment. In Part B of the study, subjects will be randomly assigned to treatment with LCQ908
  • Drug: Placebo
    In Part A of the study subjects will be randomly assigned to one of two treatment sequences; 1) LCQ908 treatment, followed by washout period, followed by placebo or 2) placebo, followed by a washout period, followed by LCQ908 treatment. In Part B of the study subjects will be randomly assigned to receive placebo
  • Experimental: LCQ908

    In Part A of the study subjects will receive, in the relevant treatment sequence, an oral loading dose of LCQ908 dose followed by a lower treatment dose

    In Part B of the study, subjects randomized to receive LCQ908 will receive an oral loading dose of LCQ908 followed by a lower treatment dose.

    Intervention: Drug: LCQ908
  • Placebo Comparator: Placebo
    In Part A of the study subjects will receive placebo in the relevant treatment sequence. In Part B of the study, subjects will be randomized to receive placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of coronary artery disease
  • Elevated triglycerides
  • On medication to help lower cholesterol

Exclusion Criteria:

  • Poorly controlled diabetic patients and/or change in diabetic medication within 12 weeks of screening
  • History of myocardial infarction (heart attack) within 6 months of screening
  • History of a procedure to open a blocked coronary artery within 12 months of enrollment
  • History of Coronary Artery Bypass Graft (CABG) surgery
  • History of congestive heart failure
  • History of significant heart valve disease
Both
40 Years to 80 Years
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals
United States
 
NCT01474434
CLCQ908A2213
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

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