HypercholesterolemiaNCT01011127
Different 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 hypothesize that pravastatin and rosuvastatin may have different 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?
- pravastatin, rosuvastatin
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Aug 2010
- 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
Study population: Hypercholesterolemia
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 hypothesize that pravastatin and rosuvastatin may have different metabolic effects in hypercholesterolemic patients.
- Conditions
- Hypercholesterolemia
- Being tested
- pravastatin, rosuvastatin
- Keywords
- Statins, Insulin resistance
- 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.
pravastatin, rosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| pravastatin | Not described Receives: Drug: pravastatin, rosuvastatin | |
| rosuvastatin | Not described Receives: Drug: pravastatin, rosuvastatin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionAug 2010
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011127
- Sponsor's protocol ID
- GMC-200914
- Status last verified
- Oct 2010
- First submitted
- 10 Nov 2009
- Last updated
- 5 Oct 2010
- 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 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Metabolic Effects of Statins
- ClinicalTrials.gov ID
- NCT01011127
- Acronym / sponsor ID
- GMC-200914
- Conditions
- Hypercholesterolemia
- Keywords
- Statins, Insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 11 Nov 2009 (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 hypothesize that pravastatin and rosuvastatin may have different metabolic effects in hypercholesterolemic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pravastatin | – | Drug: pravastatin, rosuvastatin |
| rosuvastatin | – | Drug: pravastatin, rosuvastatin |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hypercholesterolemia
Key inclusion criteria (1 listed)
- Low-density lipoprotein cholesterol levels>130
Key exclusion criteria (1 listed)
- Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
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 |
|---|---|---|
| pravastatin, rosuvastatin | Drug | pravastatin, rosuvastatin |
Primary outcome
Not reported in the source record.
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 5 Oct 2010.
- Background: 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 1 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 5 Oct 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011127, 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 5 Oct 2010.