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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 Type 2 Diabetes and Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 382
- Enrollment target
- 20
- Study locations
NCT03060577: Completed Phase 2 study of Type 2 Diabetes and Atherosclerotic Cardiovascular Disease, sponsored by Novartis Pharmaceuticals.
NCT03060577 is a Phase 2 study of Type 2 Diabetes and Atherosclerotic Cardiovascular Disease that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 382 participants, below the 3,922-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060577, a Phase 2 study of Type 2 Diabetes and Atherosclerotic Cardiovascular Disease, 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).
Primary Outcome
Percent Change in LDL-C (beta-quantification) from baseline of the ORION-1 Study to Day 210 in ORION-3. A negative percentage score represents a reduction in LDL-C. Change is relative to ORION-1 Baseline, which is defined as the last available record prior to first study drug administration in ORION-1.
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 |
What the finished NCT03060577 record still lists
NCT03060577 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, below the 3,922-participant average among 327 other Type 2 Diabetes trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Inclisiran is the first listed.
NCT03060577 names 20 study sites across 12 states, led by 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: Type 2 Diabetes, Atherosclerotic Cardiovascular Disease, 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03060577's enrollment target sits among peer trials
382 55th of 327 higher than 273 of 327 other Type 2 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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