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| Sponsored by: |
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 (CHD) |
Drug: APL180 Drug: Placebo |
Phase I Phase II |
| MedlinePlus related topics: | Heart Diseases |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Active 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Active Comparator | 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| Contact: NOVARTIS | +41 61 324 1111 |
| United States, Pennsylvania | |||||
| Novartis Investigator Site | Recruiting | ||||
| Philadelphia, Pennsylvania, United States | |||||
| Contact: Novartis 862-778-8300 | |||||
| Belgium | |||||
| Novartis Investigator Site | Recruiting | ||||
| Antwerp, Belgium | |||||
| Contact +41 61 324 1111 | |||||
| Novartis Investigator Site | Recruiting | ||||
| Leuven, Belgium | |||||
| Contact: Novartis +41 61 324 1111 | |||||
| Denmark | |||||
| Novartis Investigator Site | Recruiting | ||||
| Birkenrod, Denmark | |||||
| Contact: Novartis +41 61 324 1111 | |||||
| Israel | |||||
| Novartis Investigator Site | Recruiting | ||||
| Tel-Aviv, Israel | |||||
| Contact: Novartis +41 61 324 1111 | |||||
| Netherlands | |||||
| Novartis Investigator Site | Recruiting | ||||
| Groningen, Netherlands | |||||
| Contact +41 61 324 1111 | |||||
| South Africa | |||||
| Novartis Investigator Site | Recruiting | ||||
| Bloemfontein, South Africa | |||||
| Contact: Novartis +41 61 324 1111 | |||||
| United Kingdom | |||||
| Novartis Investigator Site | Recruiting | ||||
| Harrow, United Kingdom | |||||
| Contact +41 61 324 1111 | |||||
| Novartis |
| Principal Investigator: | NOVARTIS | Novartis investigative site |
More Information
| Responsible Party: | Novartis ( External Affairs ) |
| Study ID Numbers: | CAPL180A2201 |
| First Received: | December 5, 2007 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00568594 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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