Efficacy Study of Pioglitazone and Ramipril Combination Therapy in Treating Non-diabetic Hyperten… (NCT00770497) | Clinical Trial Compass
CompletedPhase 2
Efficacy Study of Pioglitazone and Ramipril Combination Therapy in Treating Non-diabetic Hypertensive Patients.
Germany172 participantsStarted 2007-03
Plain-language summary
The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on low grade inflammation and vascular function in hypertensive patients.
Who can participate
Age range30 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has arterial hypertension.
* Is on stable treatment with an Angiotensin Converting Enzyme inhibitor at least for 12 weeks.
* Has a high sensitive C-Reactive Protein value greater than 1.0 mg/L and less than 10.0 mg/L.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion Criteria:
* Manifests or has newly detected diabetes mellitus type 2 according to World Health Organization criteria.
* Has Type 1 Diabetes.
* Has acute infections.
* Chronic inflammatory diseases which cause elevated CRP-values (e.g. rheumatic diseases, pyelonephritis or osteomyelitis).
* Use of acetyl salicylic acid and/or Non-steroidal Anti-inflammatory Drugs 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.
* Uncontrolled hypertension (repeated blood pressure greater than 180/100 mmHg for at least three times within two weeks); persistent hypotension (systolic less than 90 mmHg) or hemodynamic instability.
* Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
* History of severe or multiple allergies.
* Treatment with any other investigational drug within 3 months before trial entry.
* Has a progressive, fatal disease.
* History of drug or alcohol abuse within the last 5 years.
* A history of…
What they're measuring
1
Change in the high-sensitivity C-reactive Protein value.