Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
NCT ID: NCT00907998
Last Updated: 2009-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
104 participants
INTERVENTIONAL
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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APL180 (first dose level)
APL180
APL180 (second dose level)
APL180
Placebo
Placebo
Interventions
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APL180
APL180
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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EudraCT 2009-010877-19
Identifier Type: -
Identifier Source: secondary_id
CAPL180A2210B
Identifier Type: -
Identifier Source: org_study_id