Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
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
2 other identifiers
interventional
104
5 countries
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2009
CompletedFirst Posted
Study publicly available on registry
May 25, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedNovember 20, 2009
November 1, 2009
4 months
May 22, 2009
November 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of APL180
Throughout the study
Secondary Outcomes (4)
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
Study Arms (3)
APL180 (first dose level)
EXPERIMENTALAPL180 (second dose level)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Pinnacle Research Group
Anniston, Alabama, AL36207, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
Icon Clinical Research
San Antonio, Texas, 78230, United States
Novartis Investigator Site
Copenhagen, Denmark
Novartis Investigator Site
Mainz, Germany
Novartis Investigator Site
Mannheim, Germany
Novartis Investigator Site
Neuss, Germany
Novartis Investigator Site
Rehovot, Israel
Novartis Investigator Site
Tel Aviv, Israel
Novartis Investigator Site
Zrifin, Israel
Novartis Investigator Site
Amsterdam, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 22, 2009
First Posted
May 25, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2009
Last Updated
November 20, 2009
Record last verified: 2009-11