NCT01466608

Brief Summary

The aim of this study is to investigate the pharmacokinetics, lipid lowering effect and lipidomic profiles of 8-weeks rosuvastatin treatment by OATP1B1 genotype in hyperlipidemia patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

October 27, 2011

Last Update Submit

May 15, 2014

Conditions

Hypercholesterolemia

Keywords

OATP1B1Rosuvastatinlipidomicspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Changes of serum lipid levels from baseline for 8 weeks

    Changes of serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglyceride levels at fasting from baseline to Day 1, Day 15, Day 29, Day 43, Day 57

    Day 1, Day 15, Day 29, Day 43, Day 57

Secondary Outcomes (1)

  • Urinary and plasma levels of the lipid metabolites for 8 weeks

    Day 1, Day 15, Day 29, Day 43, Day 57

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin 20 mg will be administered once a day for 8 weeks (open-label, one-arm, single-sequence design)

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

Oral administration of rosuvastatin 20 mg once daily for 21 days.

Also known as: Crestor Tablet 20 mg manufactured by Astrazeneca
Rosuvastatin

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 35 to 55 years at the time of screening
  • Serum LDL cholesterol (LDL-C) level ≤130 mg/dL
  • Must be reliable and willing to make themselves available during the study period
  • Must be willing to give blood sample for genotyping

You may not qualify if:

  • A subject with present clinical manifestation or past medical history of hepatic, renal, respiratory, neurologic, hematologic, oncologic, psychiatric, cardiovascular or endocrine disease, except hyperlipidemia and mild hypertension (SBP \< 160 mmg, DBP \<100 mmHg).
  • Administration of lipid lowering agent within 2 weeks before the first study drug administration.
  • A subject with a history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which could influence the absorption of the study drug.
  • A subject with a history of drug abuse, or a positive urine drug screening test
  • A subject who takes or should take any medication that can influence lipid lowering effects or metabolic profiles of the study drug during the study period. (Investigators judge the wash-out period of the previously used medication before the administration of the study drug.)
  • A subject who has participated in any other clinical trial within 3 months before the study drug administration.
  • A subject who is judged to be ineligible to participate in the study due to abnormal clinical laboratory results or other reasons by investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Seoul National University Hospital

Seoul, 110-799, South Korea

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Young Min Cho, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 8, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2013

Study Completion

August 1, 2013

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

KR(1)