HypercholesterolemiaNCT00546559
Differential Metabolic Effects of Statins
An observational study of Hypercholesterolemia, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- statins (simvastatin, pravastatin)
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2004to Mar 2008
- Phase
- Observational
- 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 25 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Low-density lipoprotein cholesterol levels > 130
Who cannot join
- Overt liver disease,
- Chronic renal failure
- Hypothyroidism
- Myopathy
- Uncontrolled diabetes
- Severe hypertension
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
- Conditions
- Hypercholesterolemia
- Being tested
- statins (simvastatin, pravastatin)
- Keywords
- Lipophilic statins, Insulin resistance, simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
- Medical subject headings
- Hypercholesterolemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
statins (simvastatin, pravastatin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startJan 2004
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kwang K Koh, MD,PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546559
- Sponsor's protocol ID
- GMC-200406
- Status last verified
- Aug 2008
- First submitted
- 18 Oct 2007
- Last updated
- 29 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.
PubMed 10205010
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Metabolic Effects of Statins
- ClinicalTrials.gov ID
- NCT00546559
- Acronym / sponsor ID
- GMC-200406
- Conditions
- Hypercholesterolemia
- Keywords
- Lipophilic statins, Insulin resistance, simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Mar 2008
- First posted
- 19 Oct 2007 (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.
The investigators hypothesized simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low-density lipoprotein cholesterol levels > 130
Key exclusion criteria (6 listed)
- Overt liver disease,
- Chronic renal failure
- Hypothyroidism
- Myopathy
- Uncontrolled diabetes
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 |
|---|---|---|
| statins (simvastatin, pravastatin) | Drug | – |
Primary outcome
Simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.
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 29 Aug 2008.
- Results publication: PubMed 10205010Yada T, Nakata M, Shiraishi T, Kakei M. Inhibition by simvastatin, but not pravastatin, of glucose-induced cytosolic Ca2+ signalling and insulin secretion due to blockade of L-type Ca2+ channels in rat islet beta-cells. Br J Pharmacol. 1999 Mar;126(5):1205-13. doi: 10.1038/sj.bjp.0702397.
Related trials for Hypercholesterolemia
RecruitingPhase 3
A Clinical Study of Enlicitide (MK-0616) in Adults With Hyperlipidemia in India (MK-0616-038)
Hyperlipidemia, Hypercholesterolemia
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Active, not recruiting
Italian Digital Primary Cardiovascular Prevention Study
Healthy Population
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease: A Randomized Controlled Trial
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
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.
Kwang K Koh, MD,PhD principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 1 inclusion and 6 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 29 Aug 2008. 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 South Korea. 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.
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?
Simvastatin and pravastatin may have differential metabolic effects in hypercholesterolemic patients.. 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 NCT00546559, 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 29 Aug 2008.