Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180

Completed · Phase 1 · Has a placebo group

Conditions studied: Coronary Heart Disease

In brief

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

Key facts

Study ID

NCT00907998

Run by

Novartis Pharmaceuticals

People needed

104

Starts

2009-06-01

Last updated by the study team

2009-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Icon Clinical Research — San Antonio, Texas, 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

Full record on ClinicalTrials.gov

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