HypercholesterolemiaPhase 4SPARQNCT01660191
A Study Comparing CoQ10 Levels While Taking 3 Different Statins
A Phase 4 study testing Pitavastin 4mg, Atorvastatin 20mg and Rosuvastatin 5mg in people with Hypercholesterolemia, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Pitavastin 4mg, Atorvastatin 20mg and Rosuvastatin 5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.
Read the detailed description
Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.
Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.
In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.
- Conditions
- Hypercholesterolemia
- Being tested
- Pitavastin 4mg, Atorvastatin 20mg, Rosuvastatin 5mg
- Keywords
- LDL, HDL
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastin 4mgDrug
Also called Livalo
Atorvastatin 20mgDrug
Also called Lipitor
Rosuvastatin 5mgDrug
Also called Crestor
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin 4mg | Active comparator | Pitavastatin 4mg tablet by mouth once daily for 12 weeks Receives: Drug: Atorvastatin 20mg; Drug: Rosuvastatin 5mg |
| Atorvastatin 20mg | Active comparator | Atorvastatin 20mg tablet by mouth once daily for 12 weeks Receives: Drug: Pitavastin 4mg; Drug: Rosuvastatin 5mg |
| rosuvastatin 5 mg | Active comparator | rosuvastatin 5 mg tablet by mouth once daily for 12 weeks Receives: Drug: Pitavastin 4mg; Drug: Atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Plasma CoQ10 Levels
Change in levels will be measured by taking difference between Baseline and Week 12 measures.
Measured: Change from Baseline to 12 Weeks
Secondary outcomes (5)
Changes in Major Lipid Parameters - VLDL Size
Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.
Measured: Change from Baseline to 12 Weeks
Changes to Glucose Metabolism - HbA1c and Insulin
Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
Measured: Change from Baseline to 12 weeks
Changes in HDL and LDL Size
Change in levels will be measured by difference in levels at 12 weeks
Measured: Change from Baseline to 12 Weeks
Changes to Glucose Metabolism - Fructosamine
Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.
Measured: Change from Baseline to 12 weeks
Changes HDL Particle Number and LDL Particle Number
Change in levels will be measured by difference in levels at 12 weeks.
Measured: Change from Baseline to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kowa Pharmaceuticals America, Inc., Eli Lilly and Company
- Responsible party
- Principal investigator, Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center
- Investigators
- Patrick M Moriarty, MD, FACC, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660191
- Sponsor's protocol ID
- 12943
- Acronym
- SPARQ
- Status last verified
- Nov 2016
- First submitted
- 21 May 2012
- Last updated
- 18 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)
- ClinicalTrials.gov ID
- NCT01660191
- Acronym / sponsor ID
- SPARQ / 12943
- Conditions
- Hypercholesterolemia
- Keywords
- LDL, HDL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Kowa Pharmaceuticals America, Inc., Eli Lilly and Company
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.
Detailed description
Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.
Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.
In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin 4mg | Active comparator | Drug: Atorvastatin 20mg, Drug: Rosuvastatin 5mgPitavastatin 4mg tablet by mouth once daily for 12 weeks |
| Atorvastatin 20mg | Active comparator | Drug: Pitavastin 4mg, Drug: Rosuvastatin 5mgAtorvastatin 20mg tablet by mouth once daily for 12 weeks |
| rosuvastatin 5 mg | Active comparator | Drug: Pitavastin 4mg, Drug: Atorvastatin 20mgrosuvastatin 5 mg tablet by mouth once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Pitavastin 4mgAlso: Livalo | Drug | Atorvastatin 20mg, rosuvastatin 5 mg |
| Atorvastatin 20mgAlso: Lipitor | Drug | Pitavastatin 4mg, rosuvastatin 5 mg |
| Rosuvastatin 5mgAlso: Crestor | Drug | Atorvastatin 20mg, Pitavastatin 4mg |
Primary outcome
Changes in Plasma CoQ10 Levels
Time frame: Change from Baseline to 12 Weeks
Change in levels will be measured by taking difference between Baseline and Week 12 measures.
5 secondary outcomes
Changes in Major Lipid Parameters - VLDL Size
Time frame: Change from Baseline to 12 Weeks
Changes to Glucose Metabolism - HbA1c and Insulin
Time frame: Change from Baseline to 12 weeks
Changes in HDL and LDL Size
Time frame: Change from Baseline to 12 Weeks
Changes to Glucose Metabolism - Fructosamine
Time frame: Change from Baseline to 12 weeks
Changes HDL Particle Number and LDL Particle Number
Time frame: Change from Baseline to 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patrick M Moriarty, MD, FACC principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastin 4mg, Atorvastatin 20mg and Rosuvastatin 5mg in people with Hypercholesterolemia, run by University of Kansas Medical Center at 1 site in United States.
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 2 inclusion and 7 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Plasma CoQ10 Levels (time frame: Change from Baseline to 12 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 18 Jan 2017.