Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00907998
First received: May 22, 2009
Last updated: November 19, 2009
Last verified: November 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Heart Disease |
Drug: APL180 Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability of APL180 [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics of APL180 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
- Evaluate effects of APL180 biomarkers [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
- Pharmacokinetic-pharmacodynamic relationship of APL180 [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
- Effect of APL180 on exploratory biomarkers, [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | June 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: APL180 (first dose level) | Drug: APL180 |
| Experimental: APL180 (second dose level) | Drug: APL180 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907998
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907998
Locations
| 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 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00907998 History of Changes |
| Other Study ID Numbers: | CAPL180A2210B, EudraCT 2009-010877-19 |
| Study First Received: | May 22, 2009 |
| Last Updated: | November 19, 2009 |
| Health Authority: | United States: Food and Drug Administration Israel: Ministry of Health Netherlands: Medical Ethics Review Committee (METC) Germany: Ministry of Health Denmark: Danish Medicines Agency |
Keywords provided by Novartis:
|
Coronary heart disease APL180 |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia |
Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015