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NCT01953328 Clinical Trial

Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events Clinical Trial

— AMG145  

Official title:
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) on LDL-C in Combination With Statin Therapy in Japanese Subjects With High Cardiovascular Risk and With Hyperlipidemia or Mixed Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01953328
Other study ID # 20120122
Secondary ID
Status Completed
Phase Phase 3
First received September 26, 2013
Last updated November 19, 2015
Start date October 2013
Est. completion date June 2014

Study information
Verified date November 2015
Source Amgen
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Description:

After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily [QD]) and entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period.

Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows:

- current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)

- no diagnosis of HeFH and receiving intensive lipid-lowering therapy

- no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.

Recruitment information / eligibility
Status Completed
Enrollment 409
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV - heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes, poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin
Administered orally once a day
Biological:
• Evolocumab
Administered by subcutaneous injection
Other:
• Placebo to Evolocumab
Administered by subcutaneous injection

Locations
Country Name City State
Japan Research Site Akita-shi Akita
Japan Research Site Arakawa-ku Tokyo
Japan Research Site Chiyoda-ku Tokyo
Japan Research Site Chiyoda-ku Tokyo
Japan Research Site Chofu-shi Tokyo
Japan Research Site Chuo-ku Tokyo
Japan Research Site Edogawa-ku Tokyo
Japan Research Site Fukuoka-shi Fukuoka
Japan Research Site Fukuoka-shi Fukuoka
Japan Research Site Fukuoka-shi Fukuoka
Japan Research Site Hachioji-shi Tokyo
Japan Research Site Hanamaki-shi Iwate
Japan Research Site Ibaraki-shi Osaka
Japan Research Site Itabashi-ku Tokyo
Japan Research Site Katsushika-ku Tokyo
Japan Research Site Kitakyusyu-shi Fukuoka
Japan Research Site Koriyama-shi Fukushima
Japan Research Site Koriyama-shi Fukushima
Japan Research Site Koriyama-shi Fukushima
Japan Research Site Koriyama-shi Fukushima
Japan Research Site Koriyama-shi Fukushima
Japan Research Site Koshigaya-shi Saitama
Japan Research Site Koto-ku Tokyo
Japan Research Site Kumagaya-shi Saitama
Japan Research Site Kyoto-shi Kyoto
Japan Research Site Maebashi-shi Gunma
Japan Research Site Minato-ku Tokyo
Japan Research Site Minato-ku Tokyo
Japan Research Site Morioka-shi Iwate
Japan Research Site Niiza-shi Saitama
Japan Research Site Noda-shi Chiba
Japan Research Site Osaka-shi Osaka
Japan Research Site Ota-ku Tokyo
Japan Research Site Sapporo-shi Hokkaido
Japan Research Site Sapporo-shi Hokkaido
Japan Research Site Sapporo-shi Hokkaido
Japan Research Site Sendai-shi Miyagi
Japan Research Site Sendai-shi Miyagi
Japan Research Site Sendai-shi Miyagi
Japan Research Site Setagaya-ku Tokyo
Japan Research Site Shibuya-ku Tokyo
Japan Research Site Shinagawa-ku Tokyo
Japan Research Site Shinagawa-ku Tokyo
Japan Research Site Shinagawa-ku Tokyo
Japan Research Site Shinagawa-ku Tokyo
Japan Research Site Takamatsu-shi Kagawa
Japan Research Site Takamatsu-shi Kagawa
Japan Research Site Takasaki-shi Gunma
Japan Research Site Tomigusuku-shi Okinawa
Japan Research Site Toshima-ku Tokyo
Japan Research Site Toyonaka-shi Osaka
Japan Research Site Tsuchiura-shi Ibaraki
Japan Research Site Urasoe-shi Okinawa
Japan Research Site Yokohama-shi Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Primary Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 Baseline and Week 12 No
Secondary Change From Baseline in LDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Change From Baseline in LDL-C at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in Non-HDL-C at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in Apolipoprotein B at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in Total Cholesterol at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 Baseline and Week 12 No
Secondary Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL Weeks 10 and 12 No
Secondary Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12 Week 12 No
Secondary Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in Lipoprotein(a) at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in Triglycerides at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in HDL-C at Week 12 Baseline and Week 12 No
Secondary Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12 Baseline and Weeks 10 and 12 No
Secondary Percent Change From Baseline in VLDL-C at Week 12 Baseline and Week 12 No

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