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Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril

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ClinicalTrials.gov Identifier: NCT00657865
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : August 22, 2011
Sponsor:
Information provided by (Responsible Party):
Markus Mueller, Medical University of Vienna

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: ramipril Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
Study Start Date : March 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Ramipril
Drug: ramipril
oral intake
Placebo Comparator: 2
Placebo
Drug: placebo
placebo



Primary Outcome Measures :
  1. Genome-wide gene expression measurements in skeletal muscle at baseline and in response to ramipril intake. [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00657865


Locations
Austria
Medical University Vienna, Department of Clinical Pharacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Markus Mueller, MD Medical University of Vienna, Dep. of Clinical Pharmacology

Responsible Party: Markus Mueller, Prof. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00657865     History of Changes
Other Study ID Numbers: Ram_Gep_1
2007-007276-41
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: August 22, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents