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NCT03060577 · ClinicalTrials.gov registry record · Phase 2
An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol
A Phase 2 study of Atherosclerotic Cardiovascular Disease and Type2 Diabetes, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 382
- Enrollment target
- 20
- Study locations
NCT03060577 is a Phase 2 study of Atherosclerotic Cardiovascular Disease and Type2 Diabetes that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 382 participants, below the 7,550-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT03060577, a Phase 2 study of Atherosclerotic Cardiovascular Disease and Type2 Diabetes, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 382 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).
Conditions Studied
Interventions
- DRUG Inclisiran
- DRUG Evolocumab
Study Locations (20)
Other
- Novartis Investigative Site - Québec
- Novartis Investigative Site - Québec
- Novartis Investigative Site - St. Johns
- Novartis Investigative Site - Berlin
Ontario
- Novartis Investigative Site - Brampton
- Novartis Investigative Site - London
- Novartis Investigative Site - Toronto
Quebec
- Novartis Investigative Site - Chicoutimi
- Novartis Investigative Site - Montreal
- Novartis Investigative Site - Sherbrooke
Ohio
- Novartis Investigative Site - Cincinnati
- Novartis Investigative Site - Cincinnati
Florida
- Novartis Investigative Site - Jacksonville
Indiana
- Novartis Investigative Site - Indianapolis
New York
- Novartis Investigative Site - New York
Tennessee
- Novartis Investigative Site - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2017-04-27 |
| Est. Completion | 2021-12-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03060577
The ClinicalTrials.gov registry entry for NCT03060577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,550-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (95% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Inclisiran is the first listed.
NCT03060577 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Ontario, Quebec.
Frequently Asked Questions
What is clinical trial NCT03060577 about?
NCT03060577 is a clinical study titled "An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol". This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).
What is the current status of trial NCT03060577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 382 participants. The study started on 2017-04-27. Estimated completion is 2021-12-17.
What conditions does trial NCT03060577 study?
This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease, Type2 Diabetes, Familial Hypercholesterolemia, Symptomatic Atherosclerosis.
What interventions are being tested in trial NCT03060577?
The interventions under investigation include: Inclisiran (DRUG), Evolocumab (DRUG).
Who is sponsoring clinical trial NCT03060577?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03060577 being conducted?
This trial has 20 study locations across Florida, Indiana, New York, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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