Non-diabetic hypertensive patients with a hsCRP value > 1.0 mg/L < 10.0 mg/L and pretreated with ACE inhibitors for at least 12 weeks are eligible for study participation. MedDRA version: 8.1 Level: LLT Classification code 10003601 Term: Atherosclerosis
Conditions
Interventions
Trade Name: Actos 15 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Pioglitazon
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Pioglitazone compared to a combination therapy with Ramipril and to Ramipril alone on low grade inflammation and vascular function in patients with increased cardiovascular risk and an activated inflammation. The primary efficacy variable of the study is the change of hsCRP value after 12 weeks of treatment as compared to baseline.;Secondary Objective: To investigate the effect of pioglitazone compared to a combination therapy with ramipril and to a ramipril monotherapy on several laboratory parameters such as lipids, inflammatory markers, parameter of vascular function and other parameter of special interest.;Primary end point(s): The primary efficacy variable of the study is the change of hsCRP value after 12 weeks of treatment as compared to baseline | — |
Countries
Germany
Outcome results
None listed