Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907998
• Other study ID #: CAPL180A2210B
• Secondary ID: EudraCT 2009-010
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2009
• Last updated: November 19, 2009
• Start date: June 2009

Study information

• Verified date: November 2009
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of HealthNetherlands: Medical Ethics Review Committee (METC)Germany: Ministry of HealthDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• APL180

• APL180

• Placebo

Locations

Country	Name	City	State
Denmark	Novartis Investigator Site	Copenhagen
Germany	Novartis Investigator Site	Mainz
Germany	Novartis Investigator Site	Mannheim
Germany	Novartis Investigator Site	Neuss
Israel	Novartis Investigator Site	Rehovot
Israel	Novartis Investigator Site	Tel Aviv
Israel	Novartis Investigator Site	Zrifin
Netherlands	Novartis Investigator Site	Amsterdam
United States	Pinnacle Research Group	Anniston	Alabama
United States	Novartis Investigative Site	Philadelphia	Pennsylvania
United States	Icon Clinical Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of APL180		Throughout the study	Yes
Secondary	Pharmacokinetics of APL180		Throughout the study	No
Secondary	Evaluate effects of APL180 biomarkers		Throughout the study	No
Secondary	Pharmacokinetic-pharmacodynamic relationship of APL180		Throughout the study	No
Secondary	Effect of APL180 on exploratory biomarkers,		Throughout the study	No