Oxidative StressPhase 2SIMOXNCT02256254
SIMOX - Induction of Oxidative Stress
A Phase 2 study testing Simvastatin in people with Oxidative Stress, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Feb 2015
- Phase
- Phase 2
- 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 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- healthy men
- 18-50 years
- BMI: 18-30
Who cannot join
- Total cholesterol less than 3 mmol/L
- Use of natural and herbal medicines that is affected/affects simvastatin:
- anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole
- following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder
- allergies towards any of the tested medicine
- intake of narcotics within 2 months prior to trial
- intake of supplements within 2 months prior to trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers
The purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. The study is a randomized-based, double-blinded placebo-controlled study. Each treatment group consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.
- Conditions
- Oxidative Stress
- Being tested
- Simvastatin, Placebo
- Keywords
- Oxidative stress, Simvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
2 Simvastatin capsules of 20 mg every evening for 14 days
PlaceboDrug
2 placebo capsules every evening for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Active comparator | 2 Simvastatin capsules of 20 mg every evening for 14 days Receives: Drug: Simvastatin |
| Placebo | Placebo comparator | 2 placebo capsules every evening for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of 8-oxoguanosine (nmol/24h)
Measured: Change from Baseline after fourteen days of treatment
Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
Measured: Change from Baseline after fourteen days of treatment
Secondary outcomes (4)
Malondialdehyde
Measured: Change from Baseline after fourteen days of treatment
Vitamin C
Measured: Change from Baseline after fourteen days of treatment
Vitamin E
Measured: Change from Baseline after fourteen days of treatment
Biopterin
Measured: Change from Baseline after fourteen days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi
- Responsible party
- Principal investigator, Henrik Enghusen Poulsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Henrik Enghusen Poulsen, Professor MD, Principal investigator, Department head
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256254
- Sponsor's protocol ID
- 2014-647
- Acronym
- SIMOX
- Status last verified
- Mar 2015
- First submitted
- 22 Sep 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIMOX - A Randomized, Double-blinded, Placebo Controlled Study of Simvastatins Possible Effect on Oxidative Stress on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02256254
- Acronym / sponsor ID
- SIMOX / 2014-647
- Conditions
- Oxidative Stress
- Keywords
- Oxidative stress, Simvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Klinisk Biokemisk Afdeling, Klinisk farmakologisk Afdeling, Sektion for Biomedicin Institut for Veterinær Patobiologi
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Oct 2014 (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 purpose of the study is to investigate if use of simvastatin is associated with the level of oxidative stress in humans. The association is examined by comparing changes in oxidative stress in a group treated with simvastatin with the change in a placebo group. The study is a randomized-based, double-blinded placebo-controlled study. Each treatment group consists of 20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine. A t-test will be performed to compare drug treatment with placebo. The results will be published.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Active comparator | Drug: Simvastatin2 Simvastatin capsules of 20 mg every evening for 14 days |
| Placebo | Placebo comparator | Drug: Placebo2 placebo capsules every evening for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Caucasian
- healthy men
- 18-50 years
- BMI: 18-30
Key exclusion criteria (7 listed)
- Total cholesterol less than 3 mmol/L
- Use of natural and herbal medicines that is affected/affects simvastatin:
- anion exchangers, amiodarone, amlodipine, ciclosporin, clarithromycin, colchicine, danazol, diltiazem, erythromycin, fibrates, fluconazole, fusidin acid, grape fruit juice, HIV protease inhibitors, itraconazole, ketoconazole, nefazodone, niacin, posaconazole, rifampicin, telithromycin, verapamil, vitamin K-antagonists, voriconazole
- following diseases: a Coronary vascular disease b Renal insufficiency c Hepatic insufficiency d heart failure e Previous heart arrythmia f Hypokalaemia g Low blood pressure h hyperthyroidism i muscular toxicity j galactose intolerants k Lapp Lactase deficiency l Glucose/galactose-malabsorption m Psychiatric disorder
- allergies towards any of the tested medicine
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 |
|---|---|---|
| Simvastatin2 Simvastatin capsules of 20 mg every evening for 14 days | Drug | Simvastatin |
| Placebo2 placebo capsules every evening for 14 days | Drug | Placebo |
Primary outcome
Urinary excretion of 8-oxoguanosine (nmol/24h)
Time frame: Change from Baseline after fourteen days of treatment
Urinary excretion of 8-oxodeoxyguanosine (nmol/24h)
Time frame: Change from Baseline after fourteen days of treatment
4 secondary outcomes
Malondialdehyde
Time frame: Change from Baseline after fourteen days of treatment
Vitamin C
Time frame: Change from Baseline after fourteen days of treatment
Vitamin E
Time frame: Change from Baseline after fourteen days of treatment
Biopterin
Time frame: Change from Baseline after fourteen days of 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 10 Mar 2015.
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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.
Henrik Enghusen Poulsen, Professor MD principal investigator
Department head
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simvastatin in people with Oxidative Stress, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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 10 Mar 2015. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Urinary excretion of 8-oxoguanosine (nmol/24h) (time frame: Change from Baseline after fourteen days of treatment). The study lists 2 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 10 Mar 2015.