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An Extension Trial of Inclisiran Compared to Evolocumab in Participants Wit... | Not Recruiting
An Extension Trial of Inclisiran Co... | Not Recruiting
An Extension Trial of Inclisiran Compared to Evolocumab in Participants With Cardiovascular Disease and High Cholesterol

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Medical Conditions
  • Atherosclerotic Cardiovascular Disease
  • Symptomatic Atherosclerosis
  • Type2 Diabetes
  • Familial Hypercholesterolemia
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT03060577
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
ORION-3 is a Phase II, open-label, non-randomized, active comparator extension trial 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).
Research Details
  • ORION-3, an extension of study MDCO-PCS-15-01 (ORION-1) [NCT02597127], is a Phase II, placebo-controlled, double-blind, randomized trial to evaluate the efficacy, safety, and tolerability of inclisiran (ALN-PCSSC) injection(s). All participants who completed ORION-1 (at least up to and including Day 210) and meet the study criteria will be enrolled into this study.

    ORION-3 is a long-term extension trial with an active comparator (evolocumab) in participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (diabetes, familial hypercholesterolemia) and elevated LDL-C, despite maximum tolerated dose of LDL-C lowering therapies.
Phase
Phase 2
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Inclisiran, Drug : Evolocumab

Study Arm Groups : Inclisiran, Evolocumab, Evolocumab

Intervention Type
See Interventions above
Primary Outcome Measures
    Percentage Change in LDL-C from Day 1 to Day 210 in the Inclisiran Group; Day 1, Day 210
Secondary Outcome Measures
    Percentage Change of Participants in the Inclisiran Group from Day 1 to Day 210 and to Day 1440 (or Final Visit) in LDL-C; Day 1, Day 210 and Day 1440 (or Final Visit); Change of Participants in the Inclisiran Group from Day 1 to Day 210 and to Day 1440 (or Final Visit) in LDL-C; Day 1, Day 210 and Day 1440 (or Final Visit); Percentage Change of Participants in the Inclisiran Group from Day 1 to Day 210 and to Day 1440 (or Final Visit) in PCSK9 Levels; Day 1, Day 210 and Day 1440 (or Final Visit); Change of Participants in the Inclisiran Group from Day 1 to Day 210 and to Day 1440 (or Final Visit) in PCSK9 Levels; Day 1, Day 210 and Day 1440 (or Final Visit); Percentage Change of Participants in the Inclisiran Group from Day 1 to Day 210 and to Day 1440 (or Final Visit) in Total Cholesterol, Triglycerides, HDL-C, non-HDL-C, VLDL-C, Apo-A1, Apo-B, and Lp(a); Day 1, Day 210 and Day 1440 (or Final Visit); Change of Participants in the Inclisiran Group from Day 1 to Day 210 and to Day 1440 (or Final Visit) in Total Cholesterol, Triglycerides, HDL-C, non-HDL-C, VLDL-C, Apo-A1, Apo-B, and Lp(a); Day 1, Day 210 and Day 1440 (or Final Visit); Proportion of Participants in the Inclisiran Group and the Evolocumab Group Who Attain Global Lipid Modification Targets for Their Level of ASCVD Risk; Day 210 and Day 1440 (or Final Visit); Proportion of Participants in the Evolocumab Group Who Attain Global Lipid Modification Targets for Their Level of ASCVD Risk at Day 570 (210 Days After Starting Inclisiran); Day 570; Proportion of Participants in the Inclisiran Group and the Evolocumab Group with ≥50% LDL-C Reduction; Day 210 and Day 570; Number of Participants in the Inclisiran Group and the Evolocumab Group Reaching on Treatment LDL-C Levels of <25 mg/dL, <50 mg/dL, <70 mg/dL, and <100 mg/dL; Day 210 and Day 570; Time to Lipid Lowering Effect in Participants in the Inclisiran Group and the Evolocumab Group; Day 1 through Day 1440; Change from Day 1 to Day 360 in LDL-C (Beta Quantification) of Participants in the Evolocumab Group; Day 1, Day 360; Change from Day 30 to Day 360 in Participant-Reported Scores Using the Treatment Satisfaction Questionnaire for Medication (TSQM) Questionnaire of Participants in the Inclisiran Group and the Evolocumab Group; Day 30, Day 360; Change from Day 450 to Day 720 in Participant-Reported Scores Using the TSQM Questionnaire of Participants in the Inclisiran Group; Day 450, Day 720; Participant-Reported Adherence to Self-Injectable Evolocumab; Day 30 through Day 360
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
490
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Completion of Study MDCO-PCS-15-01 and no contraindication to receiving inclisiran or evolocumab.

    2. Willing and able to give written and informed consent before initiation of any study related procedures and willing to comply with all required study procedures.

    3. Willing to self-inject.

    Exclusion Criteria:

    1. Any uncontrolled or serious disease, or any medical or surgical condition that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate's] judgment).

    2. An underlying known disease or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate), might interfere with interpretation of the clinical study results.

    3. Serious comorbid disease in which the life expectancy of the participant is shorter than the duration of the trial (for example, acute systemic infection, cancer, or other serious illnesses).

    4. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation greater than 2 times upper limit of normal (ULN); or total bilirubin elevation greater than 1.5 times ULN at study entry visit.

    5. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (for example, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion are

    - Women >2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age

    - Postmenopausal women (as defined above) and less than 55 years old with a negative pregnancy test within 24 hours of enrollment

    - Women who are surgically sterilized at least 3 months prior to enrollment

    6. Males who are unwilling to use an acceptable method of birth control during the entire study period (that is, condom with spermicide).

    7. Treatment with investigational medicinal products other than inclisiran or devices within 30 days or five half˗lives, whichever is longer.

    8. Planned use of investigational medicinal products other than inclisiran or devices during the course of the study.

    9. Participants with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients

    10. Previous or current treatment (within 90 days of study entry) with monoclonal antibodies directed towards PCSK9.

    11. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:

    - Inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator.

    - Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency).

    - Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (for example, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).

    - Involved with, or a relative of, someone directly involved in the conduct of the study.

    - Any known cognitive impairment (for example, Alzheimer's Disease).
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Edinburgh
EH16 4SA
Birmingham
B15 2TH
Manchester
M13 9WL
Exeter
EX2 5DW
Fowey
PL23 1DT
High Wycombe
HP11 2TT
Liskeard
PL14 3XA
London
NW3 2QG
Newcastle upon Tyne
NE1 4LP
Penzance
TR18 4JH
Plymouth
PL5 3JB
Saint Austell
PL26 7RL
Torpoint
PL11 2TB
Worcester
WR5 1DD
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Canada, Germany, Netherlands, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
An Open Label, Active Comparator Extension Trial to Assess the Effect of Long Term Dosing of Inclisiran and Evolocumab Given as Subcutaneous Injections in Participants With High Cardiovascular Risk and Elevated LDL-C (ORION-3)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
MDCO-PCS-16-01
Sponsor(s)
The Medicines Company
Key Dates

Recruitment Start Date

Mar 2017

Recruitment End Date

Aug 2018

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

17 Feb 2017

Date updated in source

29 Nov 2018