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Effects of Prescription Omega-3 on LDL-C in Primary Hypercholesterolemia

P

Provident Clinical Research

Status and phase

Completed
Phase 4

Conditions

Primary Hypercholesterolemia

Treatments

Drug: P-OM3
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00746811
PRV-08007

Details and patient eligibility

About

The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

Full description

This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Enrollment

32 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Men and women, ages 18-79 inclusive
  • Fasting, untreated low-density lipoprotein cholesterol (LDL-C)level in the borderline high to very high range
  • Fasting, untreated triglyceride (TG)level in the normal range
  • Provide written informed consent and authorization for protected health information

Exclusion criteria

  • CHD or CHD risk equivalent
  • Pregnancy
  • Use of lipid altering medications which cannot be stopped
  • Body mass index over 45 kg per square meter
  • Allergy or sensitivity to omega-3 fatty acids
  • Certain muscle, liver, kidney, lung or gastrointestinal conditions
  • Poorly controlled hypertension
  • Certain medications
  • Active cancers treated within prior 2 years (except non-melanoma skin cancer)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

32 participants in 2 patient groups

P-OM3 then Placebo
Other group
Description:
P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment.
Treatment:
Drug: Placebo
Drug: P-OM3
Placebo then P-OM3
Other group
Description:
Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.
Treatment:
Drug: Placebo
Drug: P-OM3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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