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Mixed HyperlipidemiaPhase 3NCT01956201

Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin

A Phase 3 study testing Atorvastatin 20mg and Fenofibrate 160mg in people with Mixed Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 30 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Mixed Hyperlipidemia
What is being tested?
Atorvastatin 20mg and Fenofibrate 160mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
476 participants
Where
30 sitesSouth Korea
Study dates
Dec 2013to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >19 years old
  • High risk patient to Coronary Heart Disease (applied to 1 or more CHD risk factor listed below)
  • Patient with Coronary Heart Disease
  • Patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm
  • Patient with diabetes(HbA1C≤9.0%)
  • 10-year risk of CHD >20%(by Framingham 10-year risk score calculation)
Show all 13Show fewer
  • At Visit 1(Screening)
  • 100mg/dl≥LDL-C, 150mg/dl≤TG≤500mg/dl
  • 4weeks of Atorvastatin 20mg monotherapy run-in period
  • LDL-C<100mg/dl, 150mg/dl≤TG≤500mg/dl
  • If treated with Atorvastatin 20mg monotherapy 4weeks prior to this study
  • At Visit 2(After 4weeks of Atorvastatin monotherapy run-in period)
  • LDL<100mg/dl, 150mg/dl≤TG≤500mg/dl

Who cannot join

  • Patients with acute artery disease within 3 months
  • Patients with congestive heart failure(NYHA class III~IV) or uncontrolled arrhythmia within 6 months
  • Patients with uncontrolled hypertension(SBP>160mmHg or DBP>95mmHg)
  • TSH>1.5X ULN
  • Patients with myopathy, rhabdomyolysis or CK>2X ULN
  • Hypersensitive to Atorvastatin and/or Fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment
Show all 17Show fewer
  • Serum Creatinine>2.5mg/dl, AST or ALT > 2X ULN
  • History of drug or alcohol abuse within 6 months
  • History of GI tract surgery or disability to drug absorption
  • Women with pregnant, breast-feeding
  • Patients with gallbladder disease
  • Patients with biliary cirrhosis
  • Patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia)
  • Patients treated with any investigational drugs within 4 weeks at the time consents are obtained
  • History of malignant tumor including leukemia, lymphoma within 5 years
  • Patients must be treated with medications prohibited for concomitant use during study period
  • Not eligible to participate for the study at the discretion of investigator

Trial locations and contacts

30 sites in 1 country.

Hyun-Kyung Oh contact

82-2-2194-0469

hkoh@ckdpharm.com

30 sites in 1 country

South Korea30 sites, 30 recruiting

  • Inje University Busan Paik Hospital

    Busan

    DaeKyung Kim

    Recruiting

  • Pusan National University Hospital

    Busan

    Sangsu Kim

    Recruiting

  • Kangwon University Hospital

    Chuncheon

    Yonghoon Kim

    Recruiting

  • Daegu Catholic University Medical Center

    Daegu

    Hosang Son

    Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    HoChan Cho

    Recruiting

  • Konyang University Hospital

    Daejeon

    Jangho Bae

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    YoungKun Ahn

    Recruiting

  • Dongguk University Ilsan Hospital

    Ilsan

    KyungAh Kim

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    SungYoon Lee

    Recruiting

  • Chonbuk National University Hospital

    Jeonju

    Jaegun Chae

    Recruiting

  • Hanyang University Guri Hospital

    Kyunggi

    Changmum Lee

    Recruiting

  • Seoul National University Hospital, Bundang

    Seongnam

    Soo Lim

    Recruiting

  • Asan Medical Center

    Seoul

    Kihoon Han

    Recruiting

  • Eulji General Hospital

    Seoul

    KyungAh Han

    Recruiting

  • Gangnam Severance Hospital

    Seoul

    Youngwon Yoon

    Recruiting

  • Kangbuk Samsung Medical Center

    Seoul

    KiChul Sung

    Recruiting

  • Kangdong Sacred Heart Hospital

    Seoul

    Duman Kim

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Singon Kim

    Recruiting

  • Korea University Huro Hospital

    Seoul

    KyungMuk Choi

    Recruiting

  • Kyunghee University Hospital at Gangdong

    Seoul

    Kyujung Ahn

    Recruiting

  • Kyunghee University Medical center

    Seoul

    Woosik Kim

    Recruiting

  • Samsung Medical Center

    Seoul

    MoonKyu Lee, M.D., Ph.D.

    Recruiting

  • Seoul National University Hospital

    Seoul

    HyeSeung Jung

    Recruiting

  • Severance Hospital

    Seoul

    Sanghak Lee

    Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul

    SangHyun Kim

    Recruiting

  • The Catholic University of Korea, St. Mary's Hospital

    Seoul

    SangHong Baik

    Recruiting

  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital

    Seoul

    HyunSik Son

    Recruiting

  • The Catholic University of korea, Yeouido St. Mary's Hospital

    Seoul

    HyukSang Kwon

    Recruiting

  • Ajou University hospital

    Suwon

    DaeJung Kim

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju

    Byungsoo Yoo

    Recruiting

Other trials in South Korea

About this study

Official title: Efficacy and Safety of Fenofibrate Added on to Atorvastatin Compared With Atorvastatin in Mixed Hypercholesterolemic Patient: Multi Center, Randomized, Double-blind, Parallel-group, Therapeutic Confirmatory Study.

The purpose of this study is to evaluate the efficacy and safety of Atorvastatin and Fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

Read the detailed description

Multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study

Primary Outcome Measure:

The mean percent change of Non-HDL Cholesterol [Time Frame: from baseline at week 8]

Secondary Outcome Measures:

The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl [Time Frame: from baseline at week 8] The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B [Time Frame: from baseline at week 4, 8] The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI [Time Frame: from baseline at week 4, 8] The mean percent change of Fibrinogen, hs-CRP [Time Frame: from baseline at week 4, 8] Safety evaluation [Time Frame: Treatment period and Extension period]

Being tested
Atorvastatin 20mg, Fenofibrate 160mg, Placebo (Fenofibrate 160 mg)
Medical subject headings
Hyperlipoproteinemia Type II

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 20mgDrug

    Also called Lipilou Tab.

    [Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)

  • Fenofibrate 160mgDrug

    Refer to Intervention Description of Atorvastatin 20mg

  • Placebo (Fenofibrate 160 mg)Other

    Also called Placebo

    Refer to Intervention Description of Atorvastatin 20mg

Study groups in NCT01956201
Study groupRoleWhat they receive
Atorvastatin 20mg, Fenofibrate 160mgExperimentalAtorvastatin 20mg, Fenofibrate 160mg: po, q.d.
Receives: Drug: Atorvastatin 20mg; Drug: Fenofibrate 160mg
Atorvastatin 20mg, PlaceboActive comparatorAtorvastatin 20mg, Placebo for Fenofibrate 160mg po, q.d.
Receives: Drug: Atorvastatin 20mg; Other: Placebo (Fenofibrate 160 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mean percent change of Non-HDL Cholesterol

    Measured: from baseline at week 8

Secondary outcomes (5)

  1. The achievement rate of LDL-C<100mg/dl, Non-HDL-C<130mg/dl

    Measured: from baseline at week 8

  2. The mean percent change of LDL-C, HDL-C, TG, TC, Apo-AI, Apo-B

    Measured: from baseline at week 4, 8

  3. The mean percent change of Non-LDL-C/HDL-C, TC/HDL-C, LDL-C/HDL-C, Apo-B/Apo-AI

    Measured: from baseline at week 4, 8

  4. The mean percent change of Fibrinogen, hs-CRP

    Measured: from baseline at week 4, 8

  5. Safety evaluation (Physical examination, Vital sign, Laboratory, AE etc.)

    Measured: Treatment period (8 weeks) and Extension period (16 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
476 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01956201
Sponsor's protocol ID
146MHL13011
Status last verified
Feb 2015
First submitted
30 Sep 2013
Last updated
4 Feb 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atorvastatin 20mg and Fenofibrate 160mg in people with Mixed Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 30 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyun-Kyung Oh (82-2-2194-0469, hkoh@ckdpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mean percent change of Non-HDL Cholesterol (time frame: from baseline at week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01956201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.

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