Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00907998
Start Date
June 1 2009
Last Update
November 20 2009
Active Locations (11)
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1
Pinnacle Research Group
Anniston, Alabama, United States, AL36207
2
Novartis Investigative Site
Philadelphia, Pennsylvania, United States
3
Icon Clinical Research
San Antonio, Texas, United States, 78230
4
Novartis Investigator Site
Copenhagen, Denmark