Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
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ClinicalTrials.gov Identifier: NCT00907998 |
Recruitment Status
:
Completed
First Posted
: May 25, 2009
Last Update Posted
: November 20, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Heart Disease | Drug: APL180 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | October 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: APL180 (first dose level) | Drug: APL180 |
Experimental: APL180 (second dose level) | Drug: APL180 |
Placebo Comparator: Placebo | Drug: Placebo |
- Safety and tolerability of APL180 [ Time Frame: Throughout the study ]
- Pharmacokinetics of APL180 [ Time Frame: Throughout the study ]
- Evaluate effects of APL180 biomarkers [ Time Frame: Throughout the study ]
- Pharmacokinetic-pharmacodynamic relationship of APL180 [ Time Frame: Throughout the study ]
- Effect of APL180 on exploratory biomarkers, [ Time Frame: Throughout the study ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907998
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 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00907998 History of Changes |
Other Study ID Numbers: |
CAPL180A2210B EudraCT 2009-010877-19 |
First Posted: | May 25, 2009 Key Record Dates |
Last Update Posted: | November 20, 2009 |
Last Verified: | November 2009 |
Keywords provided by Novartis:
Coronary heart disease APL180 |
Additional relevant MeSH terms:
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |