HyperlipidemiaNCT02582424
Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study.
A study testing PD-L0101 in people with Hyperlipidemia, run by Primus Pharmaceuticals.
Trial summary
This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- PD-L0101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Sep 2013
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either gender, in general good health, between 25-85 years old
- Serum TG 150-495 mg/dl at screening
- Serum LDL >/= 70 mg/dl at screening
- Not using any other product including drugs, medical foods, neutraceuticals or dietary supplements for control of serum lipids
- Consistent dietary habits
- Women of child bearing potential must use an accepted method of birth control
- Able to read and understand study documents including the Subject Informed Consent Document (Spanish language translation available, if needed)
Who cannot join
- serum TG <150 or >495 mg/dl at screening visit
- serum LDL<50 mg/dl at screening visit
- use of any other serum lipid modifying agent (see section 6.0) within 4 weeks of screening visit
- history of any intestinal disease that might interfere with absorption
- history of pancreatitis, inflammatory colitis or prior cholecystectomy
- any active malignancy or history of malignancy, except basal cell carcinoma or cervical carcinoma in situ curatively treated, within 3 years of the screening visit
Show all 18Show fewer
- screening AST, ALT, alkaline phosphatase, bilirubin >1.3 times the upper limit of normal for the reference laboratory
- serum creatinine >2.0
- uncontrolled diabetes mellitus (glycosylated Hgb >9)
- diabetes mellitus not on stable therapy for at least 2 months
- uncontrolled hypertension (DBP >100, SPB >160)
- unstable angina, congestive heart failure or other uncontrolled cardiac disease
- pregnant or lactating women
- known history of allergies to O-3 fatty acids, carotenoids, vitamin E or fish products
- history of substance abuse or any psychiatric condition that may impair the subject's ability to comply with the study requirements.
- Regular consumption of more than one (1) unit of alcohol daily. For the purposes of this study a unit of alcohol consists of 12 oz. of beer, 6 oz. of wine or 2 oz of hard spirits.
- any medical condition that, in the opinion of the investigator, might put the subject at undue risk or might interfere with the subject's ability to participate in the study
- participation in another clinical trial within 30 days or 6 half lives of the study agent, whichever is longer, of the screening visit
About this study
Official title: Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study
This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.
Read the detailed description
This will be an 8 week, multicenter, randomized, double blind, placebo controlled trial. The screening visit will be divided into two parts, a "pre-screen" in-clinic rapid lipid test (Cholestech) followed by a full screening blood draw to be sent to the central reference laboratory (CRL) for subjects meeting the Cholestech inclusion values for TG and LDL (see inclusion criteria below) on the pre-screen test. Subjects who do not meet the pre-screen criteria will be discharged from further participation in the study. Subjects must have pre-screen lipid values of LDL >/=70 mg/dl and triglyceride (TG) >/=180 and </=499. Subjects who meet these Cholestech criteria will have blood drawn for central reference laboratory (CRL) screening testing. For randomization, 80% of the subjects must have TG>/=200 mg/dl to proceed to the next screening step while up to 20% will be allowed to proceed to the next screening step with TG=150-199 mg/dl as long as the LDL is>/=70 mg/dl. Subjects who meet the CRL pre-screen lipid inclusion criteria will return 2-14 days later for the remainder of the full screening procedures. Subjects who meet all screening criteria will be randomized at this visit. Thus, the prescreening and screening-1 visits will occur at the same time and the screening 2 visit will also be the baseline visit. BMI will be calculated but is not a criterion for participation.
Subjects who meet all inclusion and exclusion requirements at the screening 2/baseline visit will be randomized to receive one of the two (2) study products. Randomization will proceed in groups of 5 with 4 subjects having TG between 200-499 mg/dl before randomizing a subject with TG between 150-199 mg/dl. Subjects will return for evaluation 4 and 8 weeks after the baseline visit at which times adverse events (AEs) will be recorded, blood lipid studies will be done and subjects will complete a VAS for product tolerability. Laboratory studies will be drawn after subjects have been sitting for at least 5 minutes.
- Conditions
- Hyperlipidemia
- Being tested
- PD-L0101, placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L0101Other
92% EPA+6 mg ATX+50 mg TCT GG BID
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| PDL-0101 | Experimental | EPA +astaxanthin Receives: Other: PD-L0101 |
| placebo | Placebo comparator | olive oil Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowering serum TG levels
more effective than placebo at lowering serum TG levels
Measured: 8 weeks
Secondary outcomes (1)
lower serum LDL levels
lower serum LDL levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Udani, MD, Principal investigator, Medicus Research 18250 Roscoe Blvd. Northridge CA 91325Andrea Lawless, MD, Principal investigator, Provident Clinical Research 211 E Lake St. Addison IL 60101
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582424
- Sponsor's protocol ID
- PDT-0101
- Status last verified
- Oct 2015
- First submitted
- 19 Oct 2015
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of PDL-0101 in Patients With Hyperlipidemias: a Pilot Study
- ClinicalTrials.gov ID
- NCT02582424
- Acronym / sponsor ID
- PDT-0101
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be an 8 week multicenter, randomized, double-blind, placebo controlled trial.
Detailed description
This will be an 8 week, multicenter, randomized, double blind, placebo controlled trial. The screening visit will be divided into two parts, a "pre-screen" in-clinic rapid lipid test (Cholestech) followed by a full screening blood draw to be sent to the central reference laboratory (CRL) for subjects meeting the Cholestech inclusion values for TG and LDL (see inclusion criteria below) on the pre-screen test. Subjects who do not meet the pre-screen criteria will be discharged from further participation in the study. Subjects must have pre-screen lipid values of LDL >/=70 mg/dl and triglyceride (TG) >/=180 and </=499. Subjects who meet these Cholestech criteria will have blood drawn for central reference laboratory (CRL) screening testing. For randomization, 80% of the subjects must have TG>/=200 mg/dl to proceed to the next screening step while up to 20% will be allowed to proceed to the next screening step with TG=150-199 mg/dl as long as the LDL is>/=70 mg/dl. Subjects who meet the CRL pre-screen lipid inclusion criteria will return 2-14 days later for the remainder of the full screening procedures. Subjects who meet all screening criteria will be randomized at this visit. Thus, the prescreening and screening-1 visits will occur at the same time and the screening 2 visit will also be the baseline visit. BMI will be calculated but is not a criterion for participation.
Subjects who meet all inclusion and exclusion requirements at the screening 2/baseline visit will be randomized to receive one of the two (2) study products. Randomization will proceed in groups of 5 with 4 subjects having TG between 200-499 mg/dl before randomizing a subject with TG between 150-199 mg/dl. Subjects will return for evaluation 4 and 8 weeks after the baseline visit at which times adverse events (AEs) will be recorded, blood lipid studies will be done and subjects will complete a VAS for product tolerability. Laboratory studies will be drawn after subjects have been sitting for at least 5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDL-0101 | Experimental | Other: PD-L0101EPA +astaxanthin |
| placebo | Placebo comparator | Other: placeboolive oil |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Either gender, in general good health, between 25-85 years old
- Serum TG 150-495 mg/dl at screening
- Serum LDL >/= 70 mg/dl at screening
- Not using any other product including drugs, medical foods, neutraceuticals or dietary supplements for control of serum lipids
- Consistent dietary habits
Key exclusion criteria (18 listed)
- serum TG <150 or >495 mg/dl at screening visit
- serum LDL<50 mg/dl at screening visit
- use of any other serum lipid modifying agent (see section 6.0) within 4 weeks of screening visit
- history of any intestinal disease that might interfere with absorption
- history of pancreatitis, inflammatory colitis or prior cholecystectomy
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 |
|---|---|---|
| PD-L010192% EPA+6 mg ATX+50 mg TCT GG BID | Other | PDL-0101 |
| placeboplacebo | Other | placebo |
Primary outcome
lowering serum TG levels
Time frame: 8 weeks
more effective than placebo at lowering serum TG levels
1 secondary outcome
lower serum LDL levels
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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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.
Jay Udani, MD principal investigator
Medicus Research 18250 Roscoe Blvd. Northridge CA 91325
Andrea Lawless, MD principal investigator
Provident Clinical Research 211 E Lake St. Addison IL 60101
Questions about this trial
What is this clinical trial studying?
A study testing PD-L0101 in people with Hyperlipidemia, run by Primus Pharmaceuticals.
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 7 inclusion and 18 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 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
lowering serum TG levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2016.