HypercholesterolemiaPhase 4NCT00397826
Evaluation of the Effects of Simvastatin 40mg
A Phase 4 study testing MK0733 in people with Hypercholesterolemia, run by Cardinal Tien Hospital.
Trial summary
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- MK0733
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient, >18 years of age
- Patients with hypercholesterolemia who meet the following lipid criteria:
- primary cholesterolemia: total cholesterol>=240 mg/dl or ldl-c >= 160 mg/dl
- secondary cholesterolemia (patients with cad, dm): ldl-c>=130 mg/dl
- The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study
Who cannot join
- Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmia, unstable angina
- Hypertension (based on the atp 3 guidelines)
- Taking potent lipid-lowering agents
- Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening
About this study
Official title: Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients(MK-0733-265)
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
Read the detailed description
This is an open-label, prospective study to investigate lipid-lowering efficacy and sympathetic response of normotensive hypercholesterolemia patients after receiving simvastatin 40 mg once daily for 3 months.
The total duration of the study will be approximately 13 weeks, comprising of a 1-week (or 4 weeks?) screening period and a 12-week active treatment period. 20 hypercholesterolemia patients with normal blood pressure will be enrolled into treatment group.
- Conditions
- Hypercholesterolemia
- Being tested
- MK0733
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0733Drug
Also called simvastatin
Duration of Treatment: 12 Weeks
| Study group | Role | What they receive |
|---|---|---|
| MK0733,simvastatin | Other | 20 patients with total cholesterol ≧ 240 mg/dL or LDL-C > 160 mg/dL for primary hypercholesterolemia; LDL-C ≧ 130 mg/dL for secondary hypercholesterolemia with identifiable risk factors will be enrolled into study to receive simvastatin 40 mg once daily for 12 weeks. Receives: Drug: MK0733 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol, ldl-c, hdl-c, and triglycerides
Measured: after 12 weeks treatment
Secondary outcomes (3)
Pulse wave velocity
Measured: after 12 weeks
Baroreflex sensitivity
Measured: after 12 weeks treatment
Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment
Measured: after 12 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startJan 2005
- Primary completionJan 2006
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardinal Tien Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Feng Yeih, Cardinal Tien Hospital
- Investigators
- Dong Feng Yeih, MD,Phd, Principal investigator, Cardinal Tiem Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397826
- Sponsor's protocol ID
- 0733-265
- Status last verified
- Jan 2016
- First submitted
- 9 Nov 2006
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Simvastatin 40 Mg on Lipid Profiles and Specified Circulatory Parameters in Normotensive Hypercholesterolemia Patients(MK-0733-265)
- ClinicalTrials.gov ID
- NCT00397826
- Acronym / sponsor ID
- 0733-265
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardinal Tien HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Nov 2006 (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.
To collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.
Detailed description
This is an open-label, prospective study to investigate lipid-lowering efficacy and sympathetic response of normotensive hypercholesterolemia patients after receiving simvastatin 40 mg once daily for 3 months.
The total duration of the study will be approximately 13 weeks, comprising of a 1-week (or 4 weeks?) screening period and a 12-week active treatment period. 20 hypercholesterolemia patients with normal blood pressure will be enrolled into treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MK0733,simvastatin | Other | Drug: MK073320 patients with total cholesterol ≧ 240 mg/dL or LDL-C > 160 mg/dL for primary hypercholesterolemia; LDL-C ≧ 130 mg/dL for secondary hypercholesterolemia with identifiable risk factors will be enrolled into study to receive simvastatin 40 mg once daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient, >18 years of age
- Patients with hypercholesterolemia who meet the following lipid criteria:
- The patient is willing to follow an NCEP therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study
Key exclusion criteria (4 listed)
- Congestive heart failure (NYHA class III or IV), uncontrolled cardiac arrhythmia, unstable angina
- Hypertension (based on the atp 3 guidelines)
- Taking potent lipid-lowering agents
- Unstable diabetes (hba1c >9%) or newly diagnosed (within 3 months), or a change in anti-diabetes medications within 3 months of screening
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 |
|---|---|---|
| MK0733Also: simvastatinDuration of Treatment: 12 Weeks | Drug | MK0733,simvastatin |
Primary outcome
Total cholesterol, ldl-c, hdl-c, and triglycerides
Time frame: after 12 weeks treatment
3 secondary outcomes
Pulse wave velocity
Time frame: after 12 weeks
Baroreflex sensitivity
Time frame: after 12 weeks treatment
Serum nitrite, nitrate and urine c-gmp levels after 12 weeks treatment
Time frame: after 12 weeks treatment
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 7 Jan 2016.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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.
Dong Feng Yeih, MD,Phd principal investigator
Cardinal Tiem Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MK0733 in people with Hypercholesterolemia, run by Cardinal Tien Hospital.
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 5 inclusion and 4 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Total cholesterol, ldl-c, hdl-c, and triglycerides (time frame: after 12 weeks treatment). 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 7 Jan 2016.