ElderlyPhase 1NCT03715101
A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly
A Phase 1 study testing Rosuvastatin in people with Elderly, run by Seoul National University Hospital.
Trial summary
A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin Read more about this study
- Who is it for?
- Ages 65 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 1
- 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 65 to 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy Subjects aged 65 - 85 years
- A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m2.
- Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.
Who cannot join
- Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- Subject judged not eligible for study participation by investigator
About this study
Official title: A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin
A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin
- Conditions
- Elderly
- Being tested
- Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Rosuvastatin 20 mg
Open-label, one-sequence, multiple administration
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 20 mg PO | Experimental | Rosuvastatin 20 mg daily for 21 days Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin
Pharmacokinetic evaluation
Measured: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin
Pharmacokinetic evaluation
Measured: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin
Pharmacokinetic evaluation
Measured: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Secondary outcomes (5)
lipid panel (low-density lipoprotein cholesterol in mg/dL)
Pharmacodynamic evaluation
Measured: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (high-density lipoprotein cholesterol in mg/dL)
Pharmacodynamic evaluation
Measured: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Triglyceride in mg/dL)
Pharmacodynamic evaluation
Measured: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Total cholesterol in units of mg/dL)
Pharmacodynamic evaluation
Measured: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid metabolites
Metabolites evaluation
Measured: Day -1 0 hour, Day 21 0 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Yong Chung, MD, PhD, Seoul National University Hospital
- Investigators
- Jae-Yong Chung, Principal investigator, South Korea Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715101
- Sponsor's protocol ID
- Rosuvastatin_Elderly
- Status last verified
- Oct 2018
- First submitted
- 19 Jul 2017
- Last updated
- 22 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate Pharmacokinetic, Pharmacodynamic, and Pharmacogenomic Characteristics of Rosuvastatin in the Elderly After Multiple Administration of Rosuvastatin
- ClinicalTrials.gov ID
- NCT03715101
- Acronym / sponsor ID
- Rosuvastatin_Elderly
- Conditions
- Elderly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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.
A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 20 mg PO | Experimental | Drug: RosuvastatinRosuvastatin 20 mg daily for 21 days |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Healthy Subjects aged 65 - 85 years
- A body mass index (BMI) in the range of 18.5 kg/m2 - 27.0 kg/m2.
- Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.
Key exclusion criteria (2 listed)
- Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
- Subject judged not eligible for study participation by investigator
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 |
|---|---|---|
| RosuvastatinAlso: Rosuvastatin 20 mgOpen-label, one-sequence, multiple administration | Drug | Rosuvastatin 20 mg PO |
Primary outcome
Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin
Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic evaluation
Pharmacokinetic parameters (Cmax; peak plasma concentration) of rosuvastatin
Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic evaluation
Pharmacokinetic parameters (AUC; area under the concentration-time curve) of rosuvastatin
Time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour
Pharmacokinetic evaluation
5 secondary outcomes
lipid panel (low-density lipoprotein cholesterol in mg/dL)
Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (high-density lipoprotein cholesterol in mg/dL)
Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Triglyceride in mg/dL)
Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid panel (Total cholesterol in units of mg/dL)
Time frame: Day 1 0 hour, Day 11 0 hour, Day 22 0 hour
lipid metabolites
Time frame: Day -1 0 hour, Day 21 0 hour
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 22 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jae-Yong Chung principal investigator
South Korea Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin in people with Elderly, run by Seoul National University 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 3 inclusion and 2 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 22 Oct 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic parameters (Tmax; time to reach maximum plasma concentration) of rosuvastatin (time frame: Day 21 0 hour, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour, 8 hour, 12 hour, 24 hour). The study lists 3 primary outcomes in all. 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 22 Oct 2018.