Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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: 78
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, California
Novartis Investigative Site Recruiting
Pasadena, California, United States, 91105
United States, Florida
Novartis Investigative Site Not yet recruiting
Hollywood, Florida, United States, 33021
United States, Louisiana
Novartis Investigative Site Not yet recruiting
Baton Rouge, Louisiana, United States, 70808-4124
United States, North Carolina
Novartis Investigative Site Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Novartis Investigative Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Novartis Investigative Site Not yet recruiting
Knoxville, Tennessee, United States, 37920
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: May 30, 2014
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
Coronary Disease
Hypertriglyceridemia
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Dyslipidemias
Heart Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014