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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
APL180
APL180
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Heart Disease focused on measuring Coronary heart disease, APL180

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pinnacle Research Group
  • Novartis Investigative Site
  • Icon Clinical Research
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site
  • Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

APL180 (first dose level)

APL180 (second dose level)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of APL180

Secondary Outcome Measures

Pharmacokinetics of APL180
Evaluate effects of APL180 biomarkers
Pharmacokinetic-pharmacodynamic relationship of APL180
Effect of APL180 on exploratory biomarkers,

Full Information

First Posted
May 22, 2009
Last Updated
November 19, 2009
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00907998
Brief Title
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

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary heart disease, APL180

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APL180 (first dose level)
Arm Type
Experimental
Arm Title
APL180 (second dose level)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
APL180
Intervention Type
Drug
Intervention Name(s)
APL180
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and tolerability of APL180
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Pharmacokinetics of APL180
Time Frame
Throughout the study
Title
Evaluate effects of APL180 biomarkers
Time Frame
Throughout the study
Title
Pharmacokinetic-pharmacodynamic relationship of APL180
Time Frame
Throughout the study
Title
Effect of APL180 on exploratory biomarkers,
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group
City
Anniston
State/Province
Alabama
ZIP/Postal Code
AL36207
Country
United States
Facility Name
Novartis Investigative Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Icon Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Novartis Investigator Site
City
Copenhagen
Country
Denmark
Facility Name
Novartis Investigator Site
City
Mainz
Country
Germany
Facility Name
Novartis Investigator Site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigator Site
City
Neuss
Country
Germany
Facility Name
Novartis Investigator Site
City
Rehovot
Country
Israel
Facility Name
Novartis Investigator Site
City
Tel Aviv
Country
Israel
Facility Name
Novartis Investigator Site
City
Zrifin
Country
Israel
Facility Name
Novartis Investigator Site
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

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