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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00568594 |
Purpose
The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180 administered as a single intravenous infusion in healthy volunteers, and (2) the safety, pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of APL018 in patients with CHD
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Drug: APL180 Drug: Placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study |
| Official Title: | A First-in-human, Randomized, Double-blind, Placebo-controlled, Single-ascending Dose (Healthy Volunteers and CHD Patients) and Multiple Dose (CHD Patients) Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180 |
| Enrollment: | 176 |
| Study Start Date: | November 2007 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental | Drug: APL180 |
| 2: Placebo Comparator | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria for both healthy volunteers and patients:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, Pennsylvania | |
| Novartis Investigator Site | |
| Philadelphia, Pennsylvania, United States | |
| Belgium | |
| Novartis Investigator Site | |
| Antwerp, Belgium | |
| Denmark | |
| Novartis Investigator Site | |
| Birkeroed, Denmark | |
| Israel | |
| Novartis Investigator Site | |
| Tel-Aviv, Israel | |
| Novartis Investigator Site | |
| Jerusalem, Israel | |
| Novartis Investigator Site | |
| Tzrifin, Israel | |
| Netherlands | |
| Novartis Investigator Site | |
| Groningen, Netherlands | |
| South Africa | |
| Novartis Investigator Site | |
| Bloemfontein, South Africa | |
| Novartis Investigator Site | |
| George, South Africa | |
| Novartis Investigator Site | |
| Port Elizabeth, South Africa | |
| United Kingdom | |
| Novartis Investigator Site | |
| Harrow, United Kingdom | |
| Principal Investigator: | NOVARTIS | Novartis investigative site |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CAPL180A2201 |
| Study First Received: | December 5, 2007 |
| Last Updated: | October 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00568594 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United States: Food and Drug Administration; Israel: Ministry of Health; South Africa: Medicines Control Council; Belgium: Federal Agency for Medicinal Products and Health Products; Denmark: Danish Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Apolipoprotein A-I, Atherosclerosis, HDL, Inflammation, |
|
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |