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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00907998
First received: May 22, 2009
Last updated: November 19, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Heart Disease
 Drug: APL180
Drug: Placebo
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability of APL180 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of APL180 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Evaluate effects of APL180 biomarkers [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Pharmacokinetic-pharmacodynamic relationship of APL180 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Effect of APL180 on exploratory biomarkers, [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: June 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: APL180 (first dose level) Drug: APL180
Experimental: APL180 (second dose level) Drug: APL180
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907998

Locations
United States, Alabama
Pinnacle Research Group
Anniston, Alabama, United States, AL36207
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
United States, Texas
Icon Clinical Research
San Antonio, Texas, United States, 78230
Denmark
Novartis Investigator Site
Copenhagen, Denmark
Germany
Novartis Investigator Site
Mainz, Germany
Novartis Investigator Site
Mannheim, Germany
Novartis Investigator Site
Neuss, Germany
Israel
Novartis Investigator Site
Rehovot, Israel
Novartis Investigator Site
Tel Aviv, Israel
Novartis Investigator Site
Zrifin, Israel
Netherlands
Novartis Investigator Site
Amsterdam, Netherlands
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00907998     History of Changes
Other Study ID Numbers: CAPL180A2210B, EudraCT 2009-010877-19
Study First Received: May 22, 2009
Last Updated: November 19, 2009
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Germany: Ministry of Health
Denmark: Danish Medicines Agency

Keywords provided by Novartis:
Coronary heart disease
APL180

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 13, 2013