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Efficacy of LCQ908 on Cardiovascular Risk (im)

This study is currently recruiting participants.
Verified October 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01474434
First received: November 9, 2011
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Hypertriglyceridemia
 Drug: LCQ908
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of LCQ908 on Cardiovascular Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 52
Study Start Date: November 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 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
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
 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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474434

Contacts
Contact: Novartis Pharmaceuticals +1(862)778-8300

Locations
United States, California
Novartis Investigative Site Recruiting
Pasadena, California, United States, 91105
United States, North Carolina
Novartis Investigative Site Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Texas
Novartis Investigative Site Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01474434     History of Changes
Other Study ID Numbers: CLCQ908A2213
Study First Received: November 9, 2011
Last Updated: October 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
coronary artery disease
LCQ908
hyperlipidemia
hypertriglyceridemia

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypertriglyceridemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013