Clinical Trials Logo
  1. Home
  2. Primary Hypercholesterolemia
  3. NCT01849497
  4. Details
NCT01849497 Clinical Trial

Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen

Primary Hypercholesterolemia Clinical Trial

Official title:
A Multi-center, Randomized Study in Subjects With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects' Ability to Administer a Full Dose of Evolocumab (AMG 145) in Home-use, Using Either a Prefilled Syringe or a Prefilled Autoinjector/Pen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01849497
Other study ID # 20120348
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 18, 2013

Study information
Verified date November 2018
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study was to assess users' ability to administer a full dose of evolocumab in home-use using either a pre-filled syringe or autoinjector/pen.

Recruitment information / eligibility
Status Completed
Enrollment 149
Est. completion date
Est. primary completion date September 2, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Fasting LDL-C at screening > 85 mg/dL

- Fasting triglycerides less than or equal to 400 mg/dL (4.5 mmol/L) Exclusion Criteria:

- New York Heart Association (NYHA) III or IV heart failure

- Uncontrolled cardiac arrhythmia

- Uncontrolled hypertension

- Type 1 diabetes or poorly controlled type 2 diabetes

- Uncontrolled hypothyroidism or hyperthyroidism

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Evolocumab Pre-filled Syringe
Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
• Evolocumab AI/pen
Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.

Locations
Country Name City State
Canada Research Site London Ontario
Canada Research Site Pointe-Claire Quebec
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Canada Research Site Woodstock Ontario
United States Research Site Atlanta Georgia
United States Research Site Atlanta Georgia
United States Research Site Auburn Maine
United States Research Site Cadiz Ohio
United States Research Site Dallas Texas
United States Research Site Duncansville Pennsylvania
United States Research Site Encino California
United States Research Site Hammond Indiana
United States Research Site Hillsboro Oregon
United States Research Site Houston Texas
United States Research Site Jackson Tennessee
United States Research Site Lansdale Pennsylvania
United States Research Site Manlius New York
United States Research Site Marion Ohio
United States Research Site Miami Florida
United States Research Site Port Charlotte Florida
United States Research Site Rapid City South Dakota
United States Research Site Syracuse New York
United States Research Site Thousand Oaks California
United States Research Site Ventura California
United States Research Site Westlake Village California

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (3)

Boccara F, Dent R, Ruilope L, Valensi P. Practical Considerations for the Use of Subcutaneous Treatment in the Management of Dyslipidaemia. Adv Ther. 2017 Aug;34(8):1876-1896. doi: 10.1007/s12325-017-0586-8. Epub 2017 Jul 17. Review. — View Citation

Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review. — View Citation

Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4 Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Week 2 and Week 4
Secondary Percent Change From Baseline in LDL-C at Week 6 Baseline and Week 6
See also
  Status Clinical Trial Phase
Recruiting NCT05559606 - An OS to Evaluate the Safety & Efficacy of Fixed Dose Combination Therapy With Atorvastatin and Ezetimibe
Completed NCT03571087 - Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia Phase 3
Completed NCT00776321 - Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia Phase 2
Recruiting NCT05399992 - Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD
Withdrawn NCT05798390 - Treatment With Bempedoic Acid And/Or Its Fixed-dose Combination With Ezetimibe in Routine Clinical Practice in Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia
Completed NCT06448962 - Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022 Phase 3
Completed NCT00724477 - Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)
Completed NCT00249249 - Study to Compare the Efficacy of Pitavastatin With That of Atorvastatin in Lowering Cholesterol Levels Phase 3
Recruiting NCT05657574 - A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia Phase 3
Completed NCT02941848 - Evaluate the Pharmacokinetics and Safety of HCP1306 and Co-administration of HGP0816, HGP1404 in Healthy Male Volunteers Phase 1
Completed NCT03516955 - Efficacy and Safety of a Generic Rosuvastatin in a Real-world Setting
Completed NCT01012219 - A Study to Evaluate the Effects of Laropiprant on the Antiplatelet Effects of Clopidogrel and Aspirin in Combination (MK-0524A-114)(COMPLETED) Phase 1
Completed NCT05131997 - A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A Phase 3
Terminated NCT03433755 - Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia Phase 3
Completed NCT00867165 - Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522) Phase 3
Not yet recruiting NCT06386419 - A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia Phase 4
Active, not recruiting NCT03952169 - Effect of Probiotics on Lipid Management N/A
Terminated NCT01335997 - Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143) Phase 3
Completed NCT02087917 - A 4-week, Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of HS-25 in Adults With Primary Hypercholesterolemia Phase 2
Completed NCT00704535 - Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

External Links