Coronary Heart Disease
Conditions
Keywords
Coronary heart disease, APL180
Brief summary
The design of this study will enable an extensive evaluation of safety, tolerability, and PK-PD relationship following 4 weeks of dosing in patients with Coronary heart Disease
Interventions
DRUGAPL180
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female CHD or CHD equivalent patients * Body mass index (BMI) must be within the range of 20 to 35 kg/m2, * Patient must have been on a stable statin therapy for \>8 weeks prior to first dose except for the statin intolerant patients.
Exclusion criteria
* Pregnancy * Significant illness within two weeks prior to dosing. * Triglycerides ≥ 500 mg/dl (5.65 mmol/l) * Uncontrolled hypertension * Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety. * Presence of NYHA Class III or IV chronic heart failure * MI or angioplasty (including stenting), acute coronary syndrome (ACS), unstable angina or arterial embolic disease within 6 months prior to do Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of APL180 | Throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of APL180 | Throughout the study |
| Evaluate effects of APL180 biomarkers | Throughout the study |
| Pharmacokinetic-pharmacodynamic relationship of APL180 | Throughout the study |
| Effect of APL180 on exploratory biomarkers, | Throughout the study |
Countries
Denmark, Germany, Israel, Netherlands, United States
Outcome results
None listed