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

• Sponsor: Veloxis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00664859
• Collaborator: (none)
• Enrollment: 140
• Location: 1
• Arm: 1
• Duration (Months): 16.1
• Patients Per Site Per Month: 8.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia	Drug: LCP-AtorFen	Phase 2/Phase 3

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Open-label LCP-AtorFen	Drug: LCP-AtorFen; 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.; Other Names: atorvastatin and fenofibrate combination therapy

Outcome Measures

Primary Outcome Measures

1. Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment [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)

Secondary Outcome Measures

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

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has successfully completed the double-blind study (LCP-AtorFen-2001; NCT00504829).

2. 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).

Exclusion Criteria:

1. Study drug compliance <70% in the double-blind study.

2. 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.

3. Resting blood pressure >/=160 mm Hg systolic and/or >/=100 mm Hg diastolic.

4. Symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.

5. Any clinically significant change in physical exam or electrocardiogram from Visit 2 to Visit 6 of the double-blind study.

6. 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.

7. 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.

8. 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.

9. Other exclusion conditions might apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiant Research, 515 N State St, Suite 2700	Chicago	Illinois	United States	60610

Sponsors and Collaborators

• Veloxis Pharmaceuticals

Investigators

• Principal Investigator: Jeff Geohas, MD, Radiant Research
• Study Director: Dennis McCluskey, MD, Radiant Resaerch
• Study Director: Harry Geisberg, MD, Radiant Research
• Study Director: Chivers Woodruff, Jr, MD, Radiant Research
• Study Director: Michael Noss, MD, Radiant Research
• Study Director: Michele Reynolds, MD, Radiant Research
• Study Director: James Zavoral, MD, Radiant Research
• Study Director: Randall Severance, MD, Radiant Research
• Study Director: Stephen Halpern, MD, Radiant Research
• Study Director: Linda Murray, MD, Radiant Research
• Study Director: Eduardo Cuevas, MD, Radiant Research
• Study Director: Cynthia Strout, MD, Coastal Carolina Research
• Study Director: Mark Kipnes, MD, Diabetes and Glandular Research Center, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Veloxis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00664859
• Other Study ID Numbers: LCP-AtorFen-2001-1X
• First Posted: Apr 23, 2008
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Veloxis Pharmaceuticals: LCP-AtorFen; Non-HDL cholesterol; Triglycerides; HDL cholesterol; LDL cholesterol; Atorvastatin; Fenofibrate
• Additional relevant MeSH terms: Dyslipidemias; Atorvastatin; Fenofibrate

Study Results

Participant Flow

Recruitment Details	Of the 192 subjects who completed the double-blind (DB) period, 140 rolled over into the extension study and received at least one dose of open-label (OL) study drug to form the safety population.

Arm/Group Title	LCP-AtorFen 40/100 mg	Atorvastatin 40 mg	Fenofibrate 145 mg
Arm/Group Description	Subjects randomized to LCP-AtorFen 40/100 mg/day in the DB portion of the study	Subjects randomized to Atorvastatin 40 mg/day in the DB portion of the study	Subjects randomized to Fenofibrate 145 mg/day in the DB portion of the study
Period Title: Overall Study
STARTED	51	45	44
COMPLETED	34	35	23
NOT COMPLETED	17	10	21

Baseline Characteristics

Arm/Group Title	LCP-AtorFen 40/100mg	Atorvastatin 40 mg	Fenofibrate 145 mg	Total
Arm/Group Description	Data presented by previous double-blind study assignment	Data presented by previous double-blind study assignment	Data presented by previous double-blind study assignment	Total of all reporting groups
Overall Participants	51	45	44	140
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.6 (10.86)	55.6 (9.03)	57.2 (11.23)	55.7 (10.41)
Sex: Female, Male (Count of Participants)
Female	18 35.3%	20 44.4%	17 38.6%	55 39.3%
Male	33 64.7%	25 55.6%	27 61.4%	85 60.7%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	2 3.9%	4 8.9%	1 2.3%	7 5%
Amer. Indian /Alaskan	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Black/African	3 5.9%	3 6.7%	1 2.3%	7 5%
Hawaiian/Other	0 0%	0 0%	0 0%	0 0%
White	46 90.2%	38 84.4%	42 95.5%	126 90%

Outcome Measures

1. Primary Outcome

Title	Change in Non-HDL Cholesterol, HDL Cholesterol, TG Levels From Baseline to End of Treatment
Description	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)
Time Frame	52 weeks from DB baseline and 40 weeks from OL baseline

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat population

Arm/Group Title	LCP-AtorFen 40/100mg	Atorvastatin 40 mg	Fenofibrate 145 mg
Arm/Group Description	Data presented by previous double-blind study assignment	Data presented by previous double-blind study assignment	Data presented by previous double-blind study assignment
Measure Participants	51	44	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)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	LCP-AtorFen 40/100mg	Atorvastatin 40 mg	Fenofibrate 145 mg
Arm/Group Description	Data presented by previous double-blind study assignment	Data presented by previous double-blind study assignment	Data presented by previous double-blind study assignment
Measure Participants	51	44	43
LDL-C change from DB baseline	-44.8 (15.92)	-39.3 (20.04)	-40.9 (22.0)
LDL-C change from OL baseline	2.1 (25.09)	14 (36.29)	-33.6 (24.26)
VLDL-C change from DB baseline	-53.6 (23.98)	-51.1 (23.07)	-42.0 (29.94)
VLDL-C change from OL baseline	12.7 (69.42)	-18.7 (39.97)	-5.5 (51.98)
Total-C change from DB baseline	-36.5 (11.07)	-33.8 (14.6)	-32.8 (16.08)
Total-C change from OL baseline	1.5 (12.95)	4.6 (24.54)	-24.4 (19.04)
Apo A-1 change from DB baseline	3.2 (13.21)	1.0 (9.88)	0.4 (12.5)
Apo-A-1 change from OL baseline	-1.4 (8.11)	1.9 (13.62)	-5.1 (11.36)
Apo B change from DB baseline	-42.4 (11.85)	-38.9 (16.26)	-36.8 (18.81)
Apo B change from OL baseline	3.1 (17.69)	-1.5 (25.14)	-25.5 (21.59)

Adverse Events

Arm/Group Title	LCP-AtorFen 40/100mg		Atorvastatin 40 mg		Fenofibrate 145 mg
Arm/Group Description	Data presented by previous double-blind study assignment		Data presented by previous double-blind study assignment		Data presented by previous double-blind study assignment
All Cause Mortality
	LCP-AtorFen 40/100mg		Atorvastatin 40 mg		Fenofibrate 145 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/45 (0%)		0/44 (0%)
Serious Adverse Events
	LCP-AtorFen 40/100mg		Atorvastatin 40 mg		Fenofibrate 145 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/51 (5.9%)		1/45 (2.2%)		3/44 (6.8%)
Gastrointestinal disorders
Appendicitis	0/51 (0%)		0/45 (0%)		1/44 (2.3%)
Injury, poisoning and procedural complications
Fracture treatment	1/51 (2%)		0/45 (0%)		0/44 (0%)
Investigations
Elevated ALT	0/51 (0%)		0/45 (0%)		1/44 (2.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/51 (2%)		0/45 (0%)		0/44 (0%)
Rectal cancer metastatic	1/51 (2%)		0/45 (0%)		0/44 (0%)
Colon cancer	0/51 (0%)		0/45 (0%)		1/44 (2.3%)
Breast cancer	0/51 (0%)		1/45 (2.2%)		0/44 (0%)
Vascular disorders
Deep vein thrombosis	0/51 (0%)		0/45 (0%)		1/44 (2.3%)
Other (Not Including Serious) Adverse Events
	LCP-AtorFen 40/100mg		Atorvastatin 40 mg		Fenofibrate 145 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/51 (23.5%)		21/45 (46.7%)		21/44 (47.7%)
Endocrine disorders
Blood glucose increased	1/51 (2%)		1/45 (2.2%)		4/44 (9.1%)
Gastrointestinal disorders
Diarrhoea	1/51 (2%)		6/45 (13.3%)		1/44 (2.3%)
Infections and infestations
Nasopharyngitis	6/51 (11.8%)		9/45 (20%)		9/44 (20.5%)
Upper respiratory tract infection	3/51 (5.9%)		6/45 (13.3%)		4/44 (9.1%)
Musculoskeletal and connective tissue disorders
Muscle spasms	1/51 (2%)		2/45 (4.4%)		3/44 (6.8%)
Renal and urinary disorders
Haematuria	0/51 (0%)		3/45 (6.7%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The study is a multicenter collaborative investigation and the clinical trial results are to be published as a collaborative manuscript. Authorship will reflect varying levels of individual contribution to the study by the individual PI's.