Clinical trial NCT00907998: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study in Patients With Coronary Heart Disease (CHD) to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of APL180
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
APL180
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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/exclusion criteria may apply

Primary outcomes:
measure: Safety and tolerability of APL180
timeFrame: Throughout the study
Secondary outcomes:
measure: Pharmacokinetics of APL180
timeFrame: Throughout the study
measure: Evaluate effects of APL180 biomarkers
timeFrame: Throughout the study
measure: Pharmacokinetic-pharmacodynamic relationship of APL180
timeFrame: Throughout the study
measure: Effect of APL180 on exploratory biomarkers,
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Icon Clinical Research
state: Texas
city: Copenhagen
country: Denmark
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Mannheim
country: Germany
facility: Novartis Investigator Site
city: Neuss
country: Germany
facility: Novartis Investigator Site
city: Rehovot
country: Israel
facility: Novartis Investigator Site
city: Tel Aviv
country: Israel
facility: Novartis Investigator Site
city: Zrifin
country: Israel
facility: Novartis Investigator Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: