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Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C (ORION-8)

Primary Purpose

ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Inclisiran Sodium

About this trial

This is an interventional treatment trial for ASCVD focused on measuring Inclisiran sodium, ASCVD, LDL-C, HeFH, HoFH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation.
Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures.

Exclusion Criteria:

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 subject at significant risk [according to investigator's (or delegate's) judgment] if he/she participates in the clinical study.
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.
Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years,
Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation >3x the upper limit of normal (ULN), or total bilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder study prior to study entry visit.
Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one method of acceptable effective contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion:
1. Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
2. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
3. Women who are surgically sterilized at least 3 months prior to enrollment.
Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study.
Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
1. Subjects who are unable to communicate or to cooperate with the investigator
2. Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
3. Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study)
4. Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study
5. Persons directly involved in the conduct of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inclisiran

Arm Description

Inclisiran sodium 300 milligrams (mg) will be administered as a single SC injection on Day 1*, 90, then every 180 days to Day 990. *Subjects who received blinded placebo in the feeder study will receive blinded inclisiran and subjects who received blinded inclisiran in the feeder study will receive blinded placebo on Day 1 in ORION-8. Subjects from the open label ORION-3 study will not receive any injection of study drug on Day 1. Their first dose of study medication will be at day 90

Outcomes

Primary Outcome Measures

Percentage of subjects achieving prespecified LDL-C targets.

A primary objective of the study is to evaluate the effect of inclisiran treatment on the proportion of subjects achieving prespecified LDL-C targets at end of study.

Incidence of Adverse Events and Serious Adverse Events

Safety assessments include adverse events and serious adverse events for long-term safety profile

Secondary Outcome Measures

Absolute and percentage change in LDL-C from baseline.

A secondary objective of this study is to evaluate the effect of inclisiran on LDL-C levels.

Absolute and percentage change in other lipids and lipoprotein from baseline.

A secondary objective of this study is to evaluate the effect of inclisiran on other lipids and lipoproteins.

Full Information

NCT ID

NCT03814187

First Posted

January 17, 2019

Last Updated

March 6, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03814187

Brief Title

Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

Acronym

ORION-8

Official Title

An Open-label Extension Trial of the Phase III Lipid-lowering Trials to Assess the Effect of Long Term Dosing of Inclisiran Given as Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

April 16, 2019 (Actual)

Primary Completion Date

February 13, 2023 (Actual)

Study Completion Date

February 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this extension study is to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study will be a global multicenter study.

Detailed Description

This study will be an open label, long term extension study in subjects with atherosclerotic cardiovascular disease (ASCVD), ASCVD-risk equivalents (eg, diabetes and familial hypercholesterolemia), or heterozygous or homozygous familial hypercholesterolemia (HeFH or HoFH) and elevated low density lipoprotein cholesterol (LDL-C) despite maximum tolerated dose of LDL-C lowering therapies who have completed the inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or any of the following Phase III lipid lowering studies: MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia, Homozygous Familial Hypercholesterolemia

Keywords

Inclisiran sodium, ASCVD, LDL-C, HeFH, HoFH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3275 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inclisiran

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Inclisiran Sodium

Intervention Description

Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Primary Outcome Measure Information:

Title

Percentage of subjects achieving prespecified LDL-C targets.

Description

A primary objective of the study is to evaluate the effect of inclisiran treatment on the proportion of subjects achieving prespecified LDL-C targets at end of study.

Time Frame

Day 1080

Title

Incidence of Adverse Events and Serious Adverse Events

Description

Safety assessments include adverse events and serious adverse events for long-term safety profile

Time Frame

Baseline, Day 1080

Secondary Outcome Measure Information:

Title

Absolute and percentage change in LDL-C from baseline.

Description

A secondary objective of this study is to evaluate the effect of inclisiran on LDL-C levels.

Time Frame

Baseline, Day 1080

Title

Absolute and percentage change in other lipids and lipoprotein from baseline.

Description

A secondary objective of this study is to evaluate the effect of inclisiran on other lipids and lipoproteins.

Time Frame

Baseline, Day 1080

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol. On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation. Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures. Exclusion Criteria: 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 subject at significant risk [according to investigator's (or delegate's) judgment] if he/she participates in the clinical study. 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. Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years, Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation >3x the upper limit of normal (ULN), or total bilirubin (TBIL) elevation >2x ULN at the last recorded visit in the feeder study prior to study entry visit. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one method of acceptable effective contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion: Women >2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization. Women who are surgically sterilized at least 3 months prior to enrollment. Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to: Subjects 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 subjects whose cooperation is doubtful due to drug abuse or alcohol dependency) Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study) Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study Persons directly involved in the conduct of the study. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Wright, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site 10001-015

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35211

Country

United States

Facility Name

Research Site 10001-138

City

Foley

State/Province

Alabama

ZIP/Postal Code

36535

Country

United States

Facility Name

Research Site 10001-113

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Research Site 10001-058

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Research Site 10001-037

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36117

Country

United States

Facility Name

Research Site 10001-076

City

Saraland

State/Province

Alabama

ZIP/Postal Code

36571

Country

United States

Facility Name

Research Site 10001-013

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Research Site 10001-077

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85213

Country

United States

Facility Name

Research Site 10001-136

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Research Site 10001-051

City

Surprise

State/Province

Arizona

ZIP/Postal Code

85374

Country

United States

Facility Name

Research Site 10001-019

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Research Site 10001-004

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Research Site 10001-132

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85745

Country

United States

Facility Name

Research Site 10001-073

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Research Site 10001-050

City

Canoga Park

State/Province

California

ZIP/Postal Code

91303

Country

United States

Facility Name

Research Site 10001-011

City

Carlsbad

State/Province

California

ZIP/Postal Code

92008

Country

United States

Facility Name

Research Site 10001-065

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Research Site 10001-150

City

Los Angeles

State/Province

California

ZIP/Postal Code

90022

Country

United States

Facility Name

Research Site 90001-005

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Research Site 10001-043

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Research Site 10001-022

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Research Site 10001-033

City

Sacramento

State/Province

California

ZIP/Postal Code

95821-2134

Country

United States

Facility Name

Research Site 10001-105

City

San Ramon

State/Province

California

ZIP/Postal Code

94582

Country

United States

Facility Name

Research Site 10001-008

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

Research Site 10001-153

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Research Site 90001-015

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Research Site 10001-044

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

Research Site 90001-047

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33434

Country

United States

Facility Name

Research Site 10001-084

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Research Site 10001-155

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Research Site 10001-099

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Research Site 10001-127

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Research Site 10001-119

City

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

Research Site 10001-070

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Research Site 10001-067

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Site 10001-139

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Research Site 10001-039

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Research Site 10001-098

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Research Site 10001-080

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Research Site 10001-081

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site 10001-140

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site 10001-142

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site 10001-030

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Research Site 10001-116

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Research Site 10001-027

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Research Site 10001-115

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33027

Country

United States

Facility Name

Research Site 10001-048

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Research Site 10001-147

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Research Site 10001-003

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33781

Country

United States

Facility Name

Research Site 10001-104

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Research Site 10001-090

City

Saint Augustine

State/Province

Florida

ZIP/Postal Code

32086

Country

United States

Facility Name

Research Site 10001-102

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Research Site 10001-123

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239-3513

Country

United States

Facility Name

Research Site 10001-143

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Research Site 10001-069

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Research Site 10001-137

City

Dunwoody

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

Research Site 10001-092

City

Macon

State/Province

Georgia

ZIP/Postal Code

31210

Country

United States

Facility Name

Research Site 10001-059

City

Arlington Heights

State/Province

Illinois

ZIP/Postal Code

60005

Country

United States

Facility Name

Research Site 10001-158

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60652

Country

United States

Facility Name

Research Site 10001-036

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Research Site 10001-082

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Research Site 10001-040

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Research Site 10001-074

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Research Site 10001-028

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502

Country

United States

Facility Name

Research Site 10001-125

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Research Site 10001-108

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40504

Country

United States

Facility Name

Research Site 10001-107

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Research Site 10001-144

City

Crowley

State/Province

Louisiana

ZIP/Postal Code

70526

Country

United States

Facility Name

Research Site 10001-041

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Research Site 10001-101

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

Research Site 90001-004

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site 10001-024

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Research Site 10001-095

City

Grandville

State/Province

Michigan

ZIP/Postal Code

49418

Country

United States

Facility Name

Research Site 10001-078

City

Sterling Heights

State/Province

Michigan

ZIP/Postal Code

48310

Country

United States

Facility Name

Research Site 10001-034

City

Troy

State/Province

Michigan

ZIP/Postal Code

48098

Country

United States

Facility Name

Research Site 10001-018

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Research Site 90001-056

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

Research Site 10001-156

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63136

Country

United States

Facility Name

Research Site 10001-007

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site 90001-012

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Research Site 10001-053

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Research Site 10001-021

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Research Site 90001-112

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Research Site 10001-124

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89121

Country

United States

Facility Name

Research Site 10001-060

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Research Site 90001-014

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Research Site 10001-055

City

Warren

State/Province

New Jersey

ZIP/Postal Code

07059

Country

United States

Facility Name

Research Site 10001-054

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Research Site 10001-122

City

Binghamton

State/Province

New York

ZIP/Postal Code

13901

Country

United States

Facility Name

Research Site 10001-128

City

Endwell

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

Research Site 10001-042

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553

Country

United States

Facility Name

Research Site 10001-129

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Research Site 10001-110

City

Williamsville

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Research Site 10001-063

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Research Site 10001-064

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Research Site 10001-145

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Facility Name

Research Site 10001-046

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Research Site 10001-016

City

Akron

State/Province

Ohio

ZIP/Postal Code

443311

Country

United States

Facility Name

Research Site 10001-120

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Research Site 90001-002

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

Facility Name

Research Site 10001-010

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Research Site 10001-134

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

Facility Name

Research Site 10001-014

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Research Site 10001-141

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45419

Country

United States

Facility Name

Research Site 10001-148

City

Marion

State/Province

Ohio

ZIP/Postal Code

43302

Country

United States

Facility Name

Research Site 10001-109

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Research Site 10001-001

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Research Site 10001-006

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Research Site 10001-075.

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Research Site 10001-111

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29588

Country

United States

Facility Name

Research Site 10001-133

City

Pelzer

State/Province

South Carolina

ZIP/Postal Code

29669

Country

United States

Facility Name

Research Site 10001-103

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Research Site 10001-146

City

Athens

State/Province

Tennessee

ZIP/Postal Code

37303

Country

United States

Facility Name

Research Site 10001-130

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Research Site 10001-118

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Research Site 10001-106

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37917

Country

United States

Facility Name

Research Site 10001-100

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Research Site 10001-087

City

Austin

State/Province

Texas

ZIP/Postal Code

78726

Country

United States

Facility Name

Research Site 10001-117

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

Research Site 10001-009

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

Facility Name

Research Site 10001-068

City

Edinburg

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

Research Site 10001-031

City

Houston

State/Province

Texas

ZIP/Postal Code

77002

Country

United States

Facility Name

Research Site 10001-088

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Research Site 10001-091

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

Facility Name

Research Site 10001-061

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Research Site 10001-032

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

Research Site 10001-057

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Research Site 10001-079

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Research Site 10001-071

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site 10001-083

City

Schertz

State/Province

Texas

ZIP/Postal Code

78154

Country

United States

Facility Name

Research Site 10001-149

City

Shavano Park

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Research Site 10001-045

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Research Site 10001-005

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

Research Site 10001-002

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

Research Site 10001-052

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

94107

Country

United States

Facility Name

Research Site 10001-093

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Research Site 10001-085

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

Research Site 10001-094

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

Facility Name

Research Site 10001-023

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Research Site 10001-029

City

Suffolk

State/Province

Virginia

ZIP/Postal Code

23435

Country

United States

Facility Name

Research Site 10001-114

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Research Site 90011-005

City

Chicoutimi

State/Province

Quebec

ZIP/Postal Code

G7H 7K9

Country

Canada

Facility Name

Research Site 90011-001

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2W 1R7

Country

Canada

Facility Name

Research Site 90011-002

City

Québec

State/Province

Quebec

ZIP/Postal Code

GIV 4W2

Country

Canada

Facility Name

Research Site 11420-002

City

Chomutov

ZIP/Postal Code

430 02

Country

Czechia

Facility Name

Research Site 90420-001

City

Praha

ZIP/Postal Code

140 21

Country

Czechia

Facility Name

Research Site 90420-006

City

Praha

ZIP/Postal Code

180 81

Country

Czechia

Facility Name

Research Site 11420-003

City

Uherské Hradiště

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Research Site 90045-001

City

Aalborg

State/Province

Nordjylland

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Research Site 90045-004

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Facility Name

Research Site 90045-003

City

Herning

ZIP/Postal Code

7400

Country

Denmark

Facility Name

Research Site 90045-006

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Research Site 90045-002

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Research Site 90045-005

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Research Site 11049-006

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

Research Site 11049-002

City

Bochum

ZIP/Postal Code

47787

Country

Germany

Facility Name

Research Site 11049-003

City

Frankfurt

ZIP/Postal Code

60313

Country

Germany

Facility Name

Research Site 11049-001

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Research Site 11049-007

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Research Site 11036-001

City

Budapest

Country

Hungary

Facility Name

Research Site 11036-004

City

Debrecen

Country

Hungary

Facility Name

Research Site 11036-002

City

Hatvan

Country

Hungary

Facility Name

Research Site 11036-003

City

Zalaegerszeg

Country

Hungary

Facility Name

Research Site 90031-001

City

Amersfoort

ZIP/Postal Code

3813 TZ

Country

Netherlands

Facility Name

Research Site 90031-003

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Research Site 90031-006

City

Goes

ZIP/Postal Code

4462 RA

Country

Netherlands

Facility Name

Research Site 90031-009

City

Hoorn

ZIP/Postal Code

1624 NP

Country

Netherlands

Facility Name

Research Site 90031-005

City

Utrecht

Country

Netherlands

Facility Name

Research SIte 11048-016

City

Brzozowie

Country

Poland

Facility Name

Research Site 11048-018

City

Bydgoszcz

ZIP/Postal Code

85-079

Country

Poland

Facility Name

Research Site 11048-011

City

Bydgoszcz

Country

Poland

Facility Name

Research Site 11048-004

City

Gdańsk

Country

Poland

Facility Name

Research Site 11048-005

City

Gdynia

Country

Poland

Facility Name

Research Site 11048-007

City

Katowice

Country

Poland

Facility Name

Research SIte 11048-012

City

Katowice

Country

Poland

Facility Name

Research Site 11048-003

City

Kraków

Country

Poland

Facility Name

Research SIte 11048-014

City

Kraków

Country

Poland

Facility Name

Research Site 11048-008

City

Lublin

Country

Poland

Facility Name

Research Site 11048-001

City

Poznań

Country

Poland

Facility Name

Research Site 11048-019

City

Ruda Śląska

ZIP/Postal Code

41-709

Country

Poland

Facility Name

Research SIte 11048-013

City

Rzeszów

Country

Poland

Facility Name

Research SIte 11048-015

City

Tarnów

Country

Poland

Facility Name

Research Site 11048-006

City

Warsaw

Country

Poland

Facility Name

Research Site 11048-009

City

Warsaw

Country

Poland

Facility Name

Research Site 11048-002

City

Wrocław

Country

Poland

Facility Name

Research Site 11048-010

City

Wrocław

Country

Poland

Facility Name

Research Site 90027-008

City

Bellville

State/Province

Cape Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Research Site 90027-007

City

Lyttelton

State/Province

Cape Town

ZIP/Postal Code

0157

Country

South Africa

Facility Name

Research Site 90027-003

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Research Site 90027-010

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Research Site 11027-005

City

Kempton Park

State/Province

Gauteng

ZIP/Postal Code

1619

Country

South Africa

Facility Name

Research Site 90027-006

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Research Site 90027-009

City

Witbank

State/Province

Gauteng

ZIP/Postal Code

1035

Country

South Africa

Facility Name

Research Site 90027-001

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Research Site 11027-007

City

Kuilsrivier

State/Province

Western Cape

ZIP/Postal Code

7580

Country

South Africa

Facility Name

Research Site 11027-013

City

Paarl

State/Province

Western Cape

ZIP/Postal Code

7646

Country

South Africa

Facility Name

Research Site 90027-004

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Research Site 90027-005

City

Somerset West

State/Province

Western Cape

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Research Site 90034-004

City

Córdoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site 90034-002

City

Zaragoza

State/Province

Aragon

ZIP/Postal Code

5009

Country

Spain

Facility Name

Research Site 90034-005

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08036

Country

Spain

Facility Name

Research Site 90034-006

City

Barcelona

State/Province

Cataluna

ZIP/Postal Code

08907

Country

Spain

Facility Name

Research Site 90034-001

City

Reus

State/Province

Cataluna

ZIP/Postal Code

43204

Country

Spain

Facility Name

Research Site 90034-003

City

La Coruña

State/Province

Galicia

ZIP/Postal Code

15002

Country

Spain

Facility Name

Research Site 90046-002

City

Göteborg

ZIP/Postal Code

SE-41346

Country

Sweden

Facility Name

Research Site 90046-001

City

Stockholm

ZIP/Postal Code

SE-11446

Country

Sweden

Facility Name

Research Site 90046-003

City

Stockholm

ZIP/Postal Code

SE-14186

Country

Sweden

Facility Name

Research Site 11380-005

City

Cherkasy

Country

Ukraine

Facility Name

Research Site 11380-008

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

Research Site 11380-001

City

Kyiv

ZIP/Postal Code

02002

Country

Ukraine

Facility Name

Research Site 11380-002

City

Kyiv

ZIP/Postal Code

03037

Country

Ukraine

Facility Name

Research Site 11380-003

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

Research Site 11380-004

City

Kyiv

Country

Ukraine

Facility Name

Research Site 11380-009

City

Zaporizhzhya

Country

Ukraine

Facility Name

Research Site 11380-006

City

Úzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Research Site 11044-028

City

Bollington

State/Province

Cheshire

ZIP/Postal Code

SK10 5JH

Country

United Kingdom

Facility Name

Research Site 11044-026

City

Bury

Country

United Kingdom

Facility Name

Research Site 11044-024

City

Cheadle Hulme

Country

United Kingdom

Facility Name

Research Site 11044-014

City

Chorley

Country

United Kingdom

Facility Name

Research Site 11044-012

City

Cornwell

Country

United Kingdom

Facility Name

Research Site 11044-010

City

Derby

Country

United Kingdom

Facility Name

Research Site 11044-006

City

Edgbaston

Country

United Kingdom

Facility Name

Research Site 11044-009

City

Exeter

Country

United Kingdom

Facility Name

Research Site 11044-001

City

Glasgow

Country

United Kingdom

Facility Name

Research Site 11044-008

City

Hexham

Country

United Kingdom

Facility Name

Research SIte 11044-020

City

Macclesfield

Country

United Kingdom

Facility Name

Research Site 11044-005

City

Manchester

Country

United Kingdom

Facility Name

Research Site 11044-025

City

Manchester

Country

United Kingdom

Facility Name

Research Site 11044-027

City

Manchester

Country

United Kingdom

Facility Name

Research Site 11044-029

City

Manchester

Country

United Kingdom

Facility Name

Research Site 11044-019

City

Plymouth

Country

United Kingdom

Facility Name

Research Site 11044-003

City

Reading

Country

United Kingdom

Facility Name

Research Site 11044-022

City

Sale

Country

United Kingdom

Facility Name

Research Site 11044-023

City

Sale

Country

United Kingdom

Facility Name

Research Site 11044-002

City

Stockton-on-Tees

Country

United Kingdom

Facility Name

Research Site 11044-021

City

Timperley

Country

United Kingdom

Facility Name

Research Site 11044-007

City

Wales

Country

United Kingdom

Facility Name

Research Site 11044-004

City

Waterloo

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

33990512

Citation

Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

Results Reference

derived

Learn more about this trial

Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C

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Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C (ORION-8)

ASCVD, Elevated Cholesterol, Heterozygous Familial Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial