Cardiovascular DiseasesPhase 2STARNCT01214746
The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man
A Phase 2 study testing Atorvastatin in people with Cardiovascular Diseases and Nephropathy, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Nephropathy
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- May 2010to Jun 2011
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, age 18-40 years
- Body Mass Index (BMI) 18,5-30 kg/m2
Who cannot join
- Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)
- Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
- Medical treatment except oral anticontraceptive
Show all 11Show fewer
- Smoking
- Pregnancy or
- Abnormal blood and urine sample
- Abnormal ECG
- Blood donation within a month before examination
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk Forskning, Regionshospitalet Holstebro
Holstebro, 7500
About this study
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.
Read the detailed description
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP), brain natriuretic (BNP) and endothelin is measured in plasma
- Conditions
- Cardiovascular Diseases, Nephropathy
- Being tested
- Placebo, Atorvastatin
- Keywords
- Statin, L-NMMA, Healthy subjects, Nephrology
- Medical subject headings
- Cardiovascular Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Unikalk
1 tablet Unikalk 1 time pr day for 5 days
AtorvastatinDrug
Also called Zarator
Zarator, 80 mg pr day for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Atorvastatin | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional excretion of sodium
Sodium excretion measured before, during and after L-NMMA infusion
Measured: 5 days treatment
Secondary outcomes (11)
Systolic blood pressure (SBP)
Measured: 5 days
Pulse wave velocity
Measured: 5 days
plasma renin concentration
Measured: 5 days
Augmentation index (AI)
Measured: 5 days
Diastolic blood pressure
Measured: 5 days
Plasma aldosterone concentration
Measured: 5 days
Plasma and urinary albumin concentration
Measured: 5 days
Urinary excretion of aquaporin-2
Measured: 5 days
plasma atrial natriuretic peptide concentration
Measured: 5 days
Plasma brain natriuretic peptide concentration
Measured: 5 days
Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Frank H Christensen, MD, Principal investigator, Medicinsk Forskning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214746
- Sponsor's protocol ID
- EBP-FHC-2010-1
- Acronym
- STAR
- Status last verified
- Aug 2011
- First submitted
- 18 May 2010
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Atorvastatin on the Nitric Oxide-system in Healthy Young Man
- ClinicalTrials.gov ID
- NCT01214746
- Acronym / sponsor ID
- STAR / EBP-FHC-2010-1
- Conditions
- Cardiovascular Diseases, Nephropathy
- Keywords
- Statin, L-NMMA, Healthy subjects, Nephrology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 Oct 2010 (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.
It has been documented that statin reduce mortality and morbidity in patients with cardiovascular disease. This effect can partly be related to a reduction in cholesterol levels in blood. Nitric oxide (NO) production is reduced in several chronic diseases such as nephropathy, diabetes and hypertension. The purpose of this study is to investigate the effect of Atorvastatin treatment on the NO-system measuring renal and cardiovascular variables in healthy man.
Detailed description
Subjects will be examined on two examination days. 4 days prior to each examination day subjects are treated with either atorvastatin or placebo. During treatment periods subject are given a standardized diet.
On the examination days subject are given L-NMMA(L-NG-monomethyl Arginine citrate), a NO inhibitor, 6 mg bolus infusion followed by continuous 4 mg/kg/hr infusion for 1 hour. Renal function, central hemodynamic and vasoactive hormones are evaluated prior, during and after L-NMMA infusion.
Renal function is measured by renal clearance of 51Cr-EDTA and urinary sodium, potassium and albumin concentration. Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)will be measured to evaluate channel activity in the nephron.
Central blood pressure, pulse wave analysis, and augmentation index are measured using SphygmoCor® from Atcor.
The vasoactive hormones aldosterone, renin, angiotensin II, atrial natriuretic peptide (ANP), brain natriuretic (BNP) and endothelin is measured in plasma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Atorvastatin | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women, age 18-40 years
- Body Mass Index (BMI) 18,5-30 kg/m2
Key exclusion criteria (11 listed)
- Arterial hypertension (>140 mmHg systolic and/or 90 mmHg diastolic)
- Anamnestic or clinical signs of heart, lung, lever, kidney and brain disease
- Neoplastic disease
- Alcohol abuse,
- Drug abuse
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 |
|---|---|---|
| PlaceboAlso: Unikalk1 tablet Unikalk 1 time pr day for 5 days | Drug | Placebo |
| AtorvastatinAlso: ZaratorZarator, 80 mg pr day for 5 days | Drug | Atorvastatin |
Primary outcome
Fractional excretion of sodium
Time frame: 5 days treatment
Sodium excretion measured before, during and after L-NMMA infusion
11 secondary outcomes
Systolic blood pressure (SBP)
Time frame: 5 days
Pulse wave velocity
Time frame: 5 days
plasma renin concentration
Time frame: 5 days
Augmentation index (AI)
Time frame: 5 days
Diastolic blood pressure
Time frame: 5 days
Plasma aldosterone concentration
Time frame: 5 days
Plasma and urinary albumin concentration
Time frame: 5 days
Urinary excretion of aquaporin-2
Time frame: 5 days
plasma atrial natriuretic peptide concentration
Time frame: 5 days
Plasma brain natriuretic peptide concentration
Time frame: 5 days
Urinary excretion of protein from sodium channels such as the NaCl cotransporter (NCC), the Na-K-Cl cotransporter (NKCC) and the epithelial sodium channel (ENaC)
Time frame: 5 days
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 16 Aug 2011.
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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.
Frank H Christensen, MD principal investigator
Medicinsk Forskning
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 Atorvastatin in people with Cardiovascular Diseases and Nephropathy, run by Regional Hospital Holstebro 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 2 inclusion and 11 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 16 Aug 2011. 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?
Fractional excretion of sodium (time frame: 5 days 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 16 Aug 2011.