NCT01660191

Brief Summary

The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 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

Study Start

First participant enrolled

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 18, 2017

Completed
Last Updated

January 18, 2017

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

May 21, 2012

Results QC Date

February 15, 2016

Last Update Submit

November 22, 2016

Conditions

Hypercholesterolemia

Keywords

LDL, HDL

Outcome Measures

Primary Outcomes (1)

  • Changes in Plasma CoQ10 Levels

    Change in levels will be measured by taking difference between Baseline and Week 12 measures.

    Change from Baseline to 12 Weeks

Secondary Outcomes (5)

  • Changes in Major Lipid Parameters - VLDL Size

    Change from Baseline to 12 Weeks

  • Changes to Glucose Metabolism - HbA1c and Insulin

    Change from Baseline to 12 weeks

  • Changes in HDL and LDL Size

    Change from Baseline to 12 Weeks

  • Changes to Glucose Metabolism - Fructosamine

    Change from Baseline to 12 weeks

  • Changes HDL Particle Number and LDL Particle Number

    Change from Baseline to 12 Weeks

Study Arms (3)

Pitavastatin 4mg

ACTIVE COMPARATOR

Pitavastatin 4mg tablet by mouth once daily for 12 weeks

Drug: Atorvastatin 20mgDrug: Rosuvastatin 5mg

Atorvastatin 20mg

ACTIVE COMPARATOR

Atorvastatin 20mg tablet by mouth once daily for 12 weeks

Drug: Pitavastin 4mgDrug: Rosuvastatin 5mg

rosuvastatin 5 mg

ACTIVE COMPARATOR

rosuvastatin 5 mg tablet by mouth once daily for 12 weeks

Drug: Pitavastin 4mgDrug: Atorvastatin 20mg

Interventions

Pitavastin 4mgDRUG
Also known as: Livalo
Atorvastatin 20mgrosuvastatin 5 mg
Atorvastatin 20mgDRUG
Also known as: Lipitor
Pitavastatin 4mgrosuvastatin 5 mg
Rosuvastatin 5mgDRUG
Also known as: Crestor
Atorvastatin 20mgPitavastatin 4mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LDL-C levels of 100-200mg/dl; triglycerides \</=200mg/dl at screening visit
  • Willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study

You may not qualify if:

  • LDL-C \<100mg/dl or \>200mg/dl, Triglycerides \>200mg/dl
  • History of diabetes mellitus or documented fasting blood glucose \>125mg/dl or HbA1c \>6.4%
  • History of coronary artery disease
  • history of chronic renal or hepatic disease
  • known sensitivity of intolerance to a statin
  • persistent elevated liver enzymes or CPK (\>3 x upper normal limit)
  • currently taking CoQ10 supplements and unable discontinue for duration of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

pitavastatinAtorvastatinRosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidines

Results Point of Contact

Title
Julie-Ann Dutton
Organization
University of Kansas Medical Center
JDUTTON@kumc.edu
913-588-4064

Study Officials

  • Patrick M Moriarty, MD, FACC

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Atherosclerosis & LDL-Apheresis Center

Study Record Dates

First Submitted

May 21, 2012

First Posted

August 8, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

January 18, 2017

Results First Posted

January 18, 2017

Record last verified: 2016-11

Locations

US(1)