EUCTR2006-004028-35-DEActive, not recruitingNot Applicable
Effect of Pioglitazone compared to a combination therapy with Ramipril and to a Ramipril monotherapy on low grade inflammation and vascular function in patients with increased cardiovascular risk and an activated inflammationA randomized double-blinded phase II study
Takeda Pharma GmbH0 sitesStarted: November 7, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1.Age 30-75 years
- •2.Arterial hypertension
- •3.Stable treatment with an ACE inhibitor at least for 12 weeks
- •4.High sensitive CRP value > 1.0 mg/L < 10.0 mg/L
- •written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Manifest or newly detected diabetes mellitus type 2 according to WHO criteria
- •2.Type 1 diabetes
- •3.Acute infections
- •4.Chronic inflammatory diseases which cause elevated CRP-values (e.g. rheumatic diseases, pyelonephritis, osteomyelitis)
- •5.Use of acetyl salicylic acid and/or NSAIDs or Cox-2-inhibitors within the last 4 weeks prior to screening visit, use of Rifampicin within the last 12 weeks prior to screening visit
- •6.Uncontrolled hypertension (repeated blood pressure > 180/100 mmHg for at least three times within two weeks); persistent hypotension (systolic < 90 mmHg) or haemodynamic instability
- •7.Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- •8.History of severe or multiple allergies
- •9.Treatment with any other investigational drug within 3 months before trial entry
- •10.Progressive fatal disease
- •11.History of drug or alcohol abuse within the last 5 years
- •12.A history of significant cardiovascular (NYHA stage I – IV, haemodynamic relevant aortic or mitral valve stenosis, hypertrophic obstructive cardiomyopathy), respiratory, gastrointestinal, hepatic (ALAT > 2.5 times the normal reference range), renal (creatinine > 2.0 mg/dL), or haematological disease, history of macular oedema
- •13.State after kidney transplantation, haemodynamic relevant renal artery stenosis (bilateral or unilateral in case of single kidney)
- •14.Blood donation within the last 30 days
- •15.Serum potassium > 5.5 mmol/L
- •16.History of hyperaldosteroism
- •17.Pregnancy or breast feeding
- •18.Sexually active women of childbearing potential not consistently and correctly practicing highly effective birth control with a low failure rate (less than 1%) such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
- •19.Lack of compliance or other similar reason, that precludes satisfactory participation in the study according to investigators’ opinion
- •20.Treatment with thiazolidinediones within 3 months prior to screening
- •21.Acute myocardial infarction, open heart surgery or cerebral events (stroke / TIA) within 30 days prior to screening visit
- •22.Patient is an employee or at least dependence of an investigator and/or the sponsor or of an institution directly involved in the study or other trials under the investigator’s direction
- •23.If statin therapy applicable: Change of medication within the last 12 weeks
- •24. History of angioneurotic oedema (hereditary or idiopatic as consequence of previous ACE-inhibitor treatment)
- •25. Dialysis or hemofiltration
- •26. LDL apheresis with dextran sulfate
- •27. Sensitation with toxic agents derived from insects
Investigators
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