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HypercholesterolemiaPhase 1NCT00652431

Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)

A Phase 1 study testing Vytorin + Niaspan, Vytorin and Niaspan in people with Hypercholesterolemia and Hyperlipidemia, run by Organon and Co.

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

This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment spans 7 days Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Hypercholesterolemia, Hyperlipidemia
What is being tested?
Vytorin + Niaspan, Vytorin and Niaspan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
May 2007to Jul 2007
Phase
Phase 1
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The subject must meet ALL the criteria listed below for entry:
  • Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules.
  • Subjects of either sex and of any race between the ages of 18 and 55 years, inclusive, having a Body Mass Index (BMI) between 19 to 32, inclusive. BMI = weight (kg)/height (m^2).
  • Subjects' clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Subject's liver function test results (AST, ALT, and GGT) must not be elevated above normal limits at Screening and on Day-1. Subjects' CPK test results must not be elevated more than 1.25 times the upper limit of normal, at Screening and on Day -1.
  • Subjects must be free of any clinically significant disease that would interfere with the study evaluations.
  • Screening ECG conduction intervals must be within gender specific normal range (QTc males <=430 msec and females <=450 msec).
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  • Vital sign measurements (taken after ~3 minutes in a seated position) must be within the following ranges:
  • oral body temperature between 35.0°C to 37.5°C
  • systolic blood pressure, 90 to 140 mm Hg
  • diastolic blood pressure, 45 to 90 mm Hg
  • pulse rate, 40 to 100 bpm
  • Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hCG) at Screening and have a negative urine pregnancy test upon each admission to the study center.
  • Women of child-bearing potential must agree to use medically accepted methods of contraception prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Acceptable methods of contraception include:
  • Condoms (male or female) with spermicide,
  • Diaphragm or cervical cap with spermicide
  • Medically prescribed IUD with spermicide, and
  • Surgical sterilization (eg. hysterectomy or tubal ligation). Vasectomy of the partner should be considered a single barrier and one additional contraceptive methods listed above must be used. Females who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
  • Female subjects must be surgically sterilized (eg, documented hysterectomy or tubal ligation) or be postmenopausal. (Defined as 12 months with no menses and with an estradiol level of <30 pg/mL.)
  • Men must agree to use a medically accepted method of contraception prior to Screening, while receiving protocol-specified medication, and for 30 days after stopping the medication.

Who cannot join

  • The subject will be excluded from entry if ANY of the criteria listed below are met:
  • Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
  • Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following and be discussed with the sponsor prior to enrollment into the trial:
  • history or presence of inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding;
  • history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
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  • history of pancreatic injury or pancreatitis;
  • history or presence of liver disease or liver injury;
  • history or presence of impaired renal function as indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or
  • history of urinary obstruction or difficulty in voiding.
  • Subject who has a history of any infectious disease within 4 weeks prior to drug administration.
  • Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
  • Subjects who have a positive screen for drugs with a high potential for abuse.
  • Subjects with a history of mental instability or who have been treated for mood disorders.
  • Subjects with a history of alcohol or drug abuse in the past 2 years.
  • Subjects who have donated blood in the past 60 days.
  • Subjects who have previously received and demonstrated intolerance to NIASPAN® (niacin extended-release tablets), VYTORIN® (ezetimibe/simvastatin), ZETIA® (ezetimibe), ZOCOR® (simvastatin) or products containing niacin/nicotinic acid.
  • Subjects who are currently participating in another clinical study or have participated in a clinical study within 30 days.
  • Subjects who are part of the study staff personnel or family members of the study staff personnel.
  • Subjects who have demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes).
  • Subjects who smoke more than 10 cigarettes or equivalent tobacco use per day.
  • Subjects who have received any treatment listed in Table 2 of protocol P04955 (Doc ID: 3498819) more recently than the indicated washout period prior to Baseline in each period.
  • Subjects who received vaccination(s) within 30 days prior to screening.

About this study

Official title: SCH 465981: Assessment of Bi-Directional Interaction Between Components of Vytorin® (Ezetimibe and Simvastatin) and Niaspan® (Niacin Extended-Release Tablets) in Healthy Subjects

This is a single-center, randomized, open-label, 3-period, 3-treatment multiple-dose crossover study designed to assess the interaction between VYTORIN® (Ezetimibe and Simvastatin) and NIASPAN® (Niacin Extended-Release Tablets) in healthy subjects. Treatment spans 7 days

Being tested
Vytorin + Niaspan, Vytorin, Niaspan
Medical subject headings
Hypercholesterolemia, Hyperlipidemias

What participants receive

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

  • Vytorin + NiaspanDrug

    Also called SCH 465981, ezetimibe, simvastatin, niacin

    Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days + Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7

  • VytorinDrug

    Also called SCH 465981, ezetimibe, simvastatin

    Vytorin (1 tablet containing ezetimibe 10 mg and simvastatin 20 mg) once daily in the morning for 7 days

  • NiaspanDrug

    Also called niacin, nicotinic acid

    Niaspan 1000 mg (1 x 1000-mg tablet) once daily in the morning on Days 1 and 2, followed by Niaspan 2000 mg (2 x 1000-mg tablets) once daily in the morning on Days 3 to 7

Study groups in NCT00652431
Study groupRoleWhat they receive
Vytorin + NiaspanExperimentalNIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 + VYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days
Receives: Drug: Vytorin + Niaspan
VytorinActive comparatorVYTORIN 10/20 mg (1 x 10/20 mg tablet containing ezetimibe 10 mg and simvastatin 20 mg) once-daily in the morning for 7 days
Receives: Drug: Vytorin
NiaspanActive comparatorNIASPAN 1000 mg (1 x 1000 mg tablet) once-daily in the morning on Days 1 to 2, followed by NIASPAN 2000 mg (2 x 1000 mg tablets) once-daily in the morning on Days 3 to 7 for a total of 7 days of treatment
Receives: Drug: Niaspan

What is being measured

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

  1. Evaluate the potential for a PK interaction between NIASPAN and components of VYTORIN, using Tmax, Cmax, and AUC.

    Measured: Day 7

Secondary outcomes (1)

  1. Evaluate safety and tolerability: laboratory test results, ECGs, adverse events, vital signs.

    Measured: throughout study

Timeline

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

  1. First posted3 Apr 2008 (estimated)
  2. Study startMay 2007
  3. Primary completionJul 2007
  4. Study completionJul 2007

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00652431
Sponsor's protocol ID
P04955
Other IDs
Doc ID: 3498819
Status last verified
Feb 2022
First submitted
31 Mar 2008
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
No

Publications

  • Kosoglou T, Zhu Y, Statkevich P, Triantafyllou I, Taggart W, Xuan F, Kim KT, Cutler DL. Assessment of potential pharmacokinetic interactions of ezetimibe/simvastatin and extended-release niacin tablets in healthy subjects. Eur J Clin Pharmacol. 2011 May;67(5):483-92. doi: 10.1007/s00228-010-0955-6. Epub 2010 Dec 1.

    PubMed 21120461

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vytorin + Niaspan, Vytorin and Niaspan in people with Hypercholesterolemia and Hyperlipidemia, run by Organon and Co.

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 19 inclusion and 23 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 16 Feb 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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?

Evaluate the potential for a PK interaction between NIASPAN and components of VYTORIN, using Tmax, Cmax, and AUC. (time frame: Day 7). 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 NCT00652431, which also lists 1 linked publication.

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 16 Feb 2022.

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