HealthyPhase 4NCT00657865
Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
A Phase 4 study testing ramipril in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ramipril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2008to Aug 2011
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Healthy defined as absence of relevant disease
- Caucasian
- Aged 18-45 years
- BMI: 18-28 kg/m2
- Signed informed consent
- Blood pressure between 110/45 and <140/90 (twice at screening)
Who cannot join
- History of renal artery stenosis
- angioneurotic edema
- psoriasis
- relevant renal diseases
- RR at screening < 110/45 mmHg.
- Diabetes, history of hypertension, RR > 140/90 at screening, cardiovascular disease
Show all 18Show fewer
- Known Diabetes mellitus of parents
- HIV or Hepatitis B/C positive virology
- Allergy or hypersensitivity against ACE-inhibitors / ramipril or to xylocain
- Contraindications against the use of the drug according to the SmPC, history of angioedema
- Any drug intake 3 weeks prior to first study day
- History of excessive bleeding tendency / hemophilia
- Presence of relevant illness within the last 3 weeks
- Suspected non-compliance with study instructions and life-style requirements
- Alcohol or drug abuse
- Blood/Plasma donation within 4 weeks prior to study day
- Previous exposure to antihypertensive drugs, ACE-inhibitors, in particular ramipril
- Current smoking (any quantity), (at least 6 months of non-smoking required)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Vienna, Department of Clinical Pharacology
Vienna, State of Vienna, 1090
About this study
This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake.
This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.
- Conditions
- Healthy
- Being tested
- ramipril, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramiprilDrug
oral intake
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ramipril Receives: Drug: ramipril |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Mueller, Medical University of Vienna
- Investigators
- Markus Mueller, MD, Principal investigator, Medical University of Vienna, Dep. of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657865
- Sponsor's protocol ID
- Ram_Gep_1
- Other IDs
- 2007-007276-41
- Status last verified
- Aug 2011
- First submitted
- 8 Apr 2008
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
- ClinicalTrials.gov ID
- NCT00657865
- Acronym / sponsor ID
- Ram_Gep_1
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Apr 2008 (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.
This project investigates the effect of ACE-inhibition on cellular metabolism by gene expression profiling of human muscle tissue, obtained by biopsy prior to and after ramipril intake.
This should contribute to our understanding of the pathomechanisms involved in diabetes and the clinical effect of ACE-inhibition on patients with diabetes/metabolic syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ramiprilRamipril |
| 2 | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Healthy defined as absence of relevant disease
- Caucasian
- Aged 18-45 years
- BMI: 18-28 kg/m2
Key exclusion criteria (18 listed)
- History of renal artery stenosis
- RR at screening < 110/45 mmHg.
- Diabetes, history of hypertension, RR > 140/90 at screening, cardiovascular disease
- Known Diabetes mellitus of parents
- HIV or Hepatitis B/C positive virology
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 |
|---|---|---|
| ramipriloral intake | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake.
Time frame: 1 year
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 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.
Markus Mueller, MD principal investigator
Medical University of Vienna, Dep. of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ramipril in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 18 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 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 Austria. 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 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?
Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake. (time frame: 1 year). 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 Aug 2011.