Efficacy of LCQ908 on Cardiovascular Risk

Coronary Artery Disease Clinical Trial

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Official title:

A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of LCQ908 on Cardiovascular Risk

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01474434
• Other study ID #: CLCQ908A2213
• Status: Terminated
• Phase: Phase 2
• First received: November 9, 2011
• Last updated: May 20, 2015
• Start date: March 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypertriglyceridemia
• Myocardial Ischemia

Intervention

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
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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Baton Rouge	Louisiana
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Pasadena	California
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Novartis Investigative Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial perfusion/coronary flow reserve (Part A and Part B of the study)		Part A; Baseline, and on day 5 of each of the 2 treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days	No
Primary	Time to onset of angina (Part A and Part B)		Part A; Baseline and on day 5 of each of the two treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days.	No
Primary	Time to onset of exercise-induced ischemia(Part A and Part B)		Part A; Baseline and on day 5 of each of the two treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days.	No
Primary	Total exercise duration (Part A and Part B)		Part A; Baseline and on day 5 of each of the two treatment periods. Part B; Baseline and on treatment day 85 +/- 3 days.	No
Primary	Aortic plaque inflammation (Part B)		Baseline and on treatment day 85 +/- 3 days	No
Secondary	Postprandial triglycerides in Part A		Part A: Day 5 of each treatment period	No
Secondary	Percentage of patients with adverse events (Part A and Part B)		Part A: approximately 40 days, Part B: Up to 85 days + 30 days follow up	Yes
Secondary	Pharmacokinetics of LCQ908: Plasma concentration		Part A: Day 4 and day 5 of each treatment period; Part B: Day 15, 29, 43, 57 and 85.	No
Secondary	Other related lipid parameters (Part A and Part B)		Part A: Baseline, day 4 and day 5 of each treatment period. Part B; Baseline, day 15, day 43 and day 85.	No
Secondary	Interleukin-6 (IL-6) level (Part A and Part B)		Part A: Baseline, day 4 and day 5, of each treatment period. Part B; Baseline, day 15, day 43 and day 85	No
Secondary	Adiponectin level ( Part B)		Part B; Baseline, day 15, day 43 and day 85	No
Secondary	C-reactive protein (CRP) level (Part A and Part B)		Part A: Baseline, day 4 and day 5, of each treatment period. Part B; Baseline, day 15, day 43 and day 85	No