DyslipidemiaPhase 2/3NCT00664859

12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia

A Phase 2/3 study testing LCP-AtorFen in people with Dyslipidemia, run by Veloxis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemia
What is being tested?: LCP-AtorFen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 140 participants
Where: 1 siteUnited States
Study dates: Oct 2007to Feb 2009
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).
Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).

Who cannot join

Study drug compliance <70% in the double-blind study.
Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug.
Resting blood pressure >/=160 mm Hg systolic and/or >/=100 mm Hg diastolic.
Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.
Any clinically significant change from Visit 1 to Visit 6 of the double-blind study in medical history including, but not limited to: a diagnosis of insulin-dependent diabetes mellitus (DM); poorly controlled DM; poorly controlled hypertension; significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease; cancer (except non-melanoma skin cancer); and epilepsy.

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Unwilling to abstain from medications, supplements, ingredients and herbal therapies that were excluded in the double-blind study and continue to be excluded in the open-label study.
Women who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential (not surgically sterilized between menarche and menopause) who are not using a medically approved method of contraception.
Other exclusion conditions might apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Radiant Research, 515 N State St, Suite 2700
Chicago, Illinois, 60610

Other trials in United States

About this study

Official title: A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

Read the detailed description

POPULATION:

Subjects with mixed dyslipidemia (non-HDL cholesterol > 130 mg/dL and TG ≥ 150 mg/dL and ≤ 500 mg/dL) who completed the double-blind study (LCP-AtorFen-2001; NCT00504829), met the enrollment criteria (all of the inclusion criteria and none of the exclusion criteria), and elected to enter the open-label extension study.

STUDY DESIGN AND DURATION:

This is a 52-week, open-label, single-treatment arm with 8 visits (Weeks 0, 4, 8, 12, 24, 36, 48 and 52). A maximum of approximately 200 subjects will enter this open-label safety and efficacy extension study from the LCP AtorFen-2001 double-blind study. All subjects enrolled in this study will receive open-label LCP-AtorFen combination therapy. Visit 1 of the extension study corresponds to the last visit of the double-blind study (Visit 6 or Week 12).

Conditions: Dyslipidemia
Being tested: LCP-AtorFen
Keywords: LCP-AtorFen, Non-HDL cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol, Atorvastatin, Fenofibrate
Medical subject headings: Dyslipidemias

What participants receive

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

LCP-AtorFenDrug
Also called atorvastatin and fenofibrate combination therapy
All subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.

Study groups in NCT00664859
Study group	Role	What they receive
Single	Experimental	Open-label LCP-AtorFen Receives: Drug: LCP-AtorFen

What is being measured

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

Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)
Measured: 52 weeks from DB baseline and 40 weeks from OL baseline

Secondary outcomes (1)

Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Mean percent changes in LDL cholesterol, VLDL, total cholesterol, Apo A-1, and Apo B from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12) to end-of-treatment (Week 52)
Measured: 52 weeks from DB baseline and 40 weeks from OL baseline

Timeline

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

Oct 2007Feb 2009

First posted23 Apr 2008 (estimated)
Study startOct 2007
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00664859
Sponsor's protocol ID: LCP-AtorFen-2001-1X
Status last verified: Mar 2020
First submitted: 21 Apr 2008
Last updated: 24 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
ClinicalTrials.gov ID: NCT00664859
Acronym / sponsor ID: LCP-AtorFen-2001-1X
Conditions: Dyslipidemia
Keywords: LCP-AtorFen, Non-HDL cholesterol, Triglycerides, HDL cholesterol, LDL cholesterol, Atorvastatin, Fenofibrate
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 23 Apr 2008 (estimated)
Results: Posted 24 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

Detailed description

POPULATION:

STUDY DESIGN AND DURATION:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single	Experimental	Drug: LCP-AtorFenOpen-label LCP-AtorFen

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).
Subject has confirmed his or her willingness to participate in this study after being informed of all aspects of the study by voluntarily signing and dating an informed consent form in accordance with Good Clinical Practice (GCP).

Key exclusion criteria (9 listed)

Study drug compliance <70% in the double-blind study.
Any ongoing serious adverse event, or any ongoing non-serious moderate or severe adverse event from the double-blind study that is rated as possibly, probably or definitely related to study drug.
Resting blood pressure >/=160 mm Hg systolic and/or >/=100 mm Hg diastolic.
Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LCP-AtorFenAlso: atorvastatin and fenofibrate combination therapyAll subjects will be assigned to receive open-label LCP-AtorFen combination therapy for 52 weeks. Subjects will take a single oral dose of study drug in the evening without regard to meals.	Drug	Single

Primary outcome

Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Time frame: 52 weeks from DB baseline and 40 weeks from OL baseline
Mean percent changes in non-HDL cholesterol, HDL cholesterol, TG levels from the double-blind (DB) baseline (Week 0) to end-of-treatment (Week 52), and from the open-label (OL) baseline (week 12 of DB study) to end of treatment (Week 52)

1 secondary outcome

Change in LDL Cholesterol, VLDL, Total Cholesterol, Apo A-1, and Apo B From Baseline to End of Treatment
Time frame: 52 weeks from DB baseline and 40 weeks from OL baseline

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCP-AtorFen 40/100 mg	51	34
Atorvastatin 40 mg	45	35
Fenofibrate 145 mg	44	23

Primary outcome: Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment

Time frame: 52 weeks from DB baseline and 40 weeks from OL baseline. Mean (Standard Deviation). Unit: percent change

Measure	LCP-AtorFen 40/100mg n = 51	Atorvastatin 40 mg n = 44	Fenofibrate 145 mg n = 43
Non-HDL cholesterol, change from DB baseline	-48.2 (13.58)	-43.6 (18.18)	-42.0 (20.49)
Non-HDL cholesterol change from OL baseline	2.6 (22.39)	2.8 (33.67)	-29.6 (26.92)
Triglycerides change from DB baseline	-53.1 (25.31)	-51.2 (23.23)	-42.1 (29.96)
Triglycerides change from OL baseline	11.4 (65.36)	-19.1 (40.42)	-5.2 (53.27)
HDL cholesterol change from DB baseline	22.1 (21.7)	16.3 (18.67)	17.5 (20.21)
HDL cholesterol change from OL baseline	2.1 (16.9)	10.1 (17.77)	-2.4 (15.4)

Population analysed: Modified intent-to-treat population

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCP-AtorFen 40/100mg	3 of 51 (5.9%)	12 of 51 (23.5%)	0 of 51
Atorvastatin 40 mg	1 of 45 (2.2%)	21 of 45 (46.7%)	0 of 45
Fenofibrate 145 mg	3 of 44 (6.8%)	21 of 44 (47.7%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dyslipidemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
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Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeff Geohas, MD principal investigator

Radiant Research

Dennis McCluskey, MD study director

Radiant Resaerch

Harry Geisberg, MD study director

Radiant Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LCP-AtorFen in people with Dyslipidemia, run by Veloxis Pharmaceuticals at 1 site in United States.

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 2 inclusion and 9 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: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment (time frame: 52 weeks from DB baseline and 40 weeks from OL baseline). 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 NCT00664859.

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 24 Mar 2020.