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OpenTrials
Completed

NCT Number: NCT00907998

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

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

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigator Site, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APL180

Drug

Placebo

Drug

Primary outcomes

  1. Safety and tolerability of APL180

    Time frame: Throughout the study

Secondary outcomes

  1. Pharmacokinetics of APL180

    Time frame: Throughout the study

  2. Evaluate effects of APL180 biomarkers

    Time frame: Throughout the study

  3. Pharmacokinetic-pharmacodynamic relationship of APL180

    Time frame: Throughout the study

  4. Effect of APL180 on exploratory biomarkers,

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
First posted
May 25, 2009
Registry last updated
Nov 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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