| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004028-35 | EudraCT Number | ||
| D-PIO-110 | Other Identifier | Takeda ID | |
| U1111-1115-9194 | Registry Identifier | WHO |
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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.
Patients with insulin resistance and an activated inflammation are prone for cardiovascular complications like myocardial infarction or stroke. Pharmacological interventions reducing vascular inflammation are thought to reduce cardiovascular risk in diabetic and in non-diabetic patients.
Intervention with ACE inhibitors like ramipril is an established and widely used treatment for patients with high blood pressure, proven to reduce cardiovascular risk. Treatment of non-diabetic patients with pioglitazone has shown to improve the cardiovascular risk profile in non-diabetic patients beyond its effect on blood glucose levels.
The purpose of this study is to evaluate effects on low grade inflammation and vascular function of pioglitazone in non-diabetic, hypertensive patients with pre treatment with angiotensin converting enzyme inhibitors (that will be replaced by the study medication at time of randomization).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone 15 mg to 30 mg QD | Experimental |
| |
| Pioglitazone 15 mg to 30 mg QD + Ramipril 2.5 mg to 5 mg QD | Active Comparator |
| |
| Ramipril 2.5 mg to 5 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | Pioglitazone 15 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and ramipril placebo-matching tablets, orally, once daily for up to 10 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the high-sensitivity C-reactive Protein value. | Week: 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Glucose tolerance as assessed by an oral glucose tolerance test. | Week: 12. | |
| Change from Baseline in Insulin sensitivity according to the Homeostatic Model Assessment - Sensitivity score and Insulin Secretion. | Weeks: 6 and 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Adviser Clinical Research | Takeda Pharma Gmbh, Aachen (Germany) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deggingen | Baden-Wurttemberg | Germany | ||||
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| Label | URL |
|---|---|
| ACTOS® Package Insert | View source |
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| Pioglitazone and ramipril | Drug | Pioglitazone 15 mg, tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks. |
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| Ramipril | Drug | Pioglitazone placebo-matching tablets, orally, once daily and ramipril 2.5 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and ramipril 5 mg, tablets, orally, once daily for up to 10 weeks. |
|
| Change from Baseline in Glycosylated Hemoglobin levels. | Week: 12. |
| Change from Baseline in C-Peptide levels. | Weeks: 6 and 12. |
| Change from Baseline in Proinsulin intact levels. | Weeks: 6 and 12. |
| Change from Baseline in 24 hours Blood Pressure Profile. | Week: 12. |
| Change from Baseline in high-sensitivity C-reactive Protein levels. | Weeks: 6 and 10. |
| Change from Baseline in Adiponectin levels. | Weeks: 6 and 12. |
| Change from Baseline in Monocyte Chemoattractant Protein-1 levels. | Weeks: 6 and 12. |
| Change from Baseline in Matrix metalloproteinase-9 levels. | Weeks: 6 and 12. |
| Change from Baseline in P-selectin levels. | Weeks: 6 and 12. |
| Change from Baseline in Plasminogen Activator Inhibitor-1 levels. | Weeks: 6 and 12. |
| Change from Baseline in Relaxin levels. | Weeks: 6 and 12. |
| Change from Baseline in Endothelin 1-21 levels. | Weeks: 6 and 12. |
| Change from Baseline in Nitrotyrosine levels. | Weeks: 6 and 12. |
| Change from Baseline in Asymmetric Dimethylarginine levels. | Weeks: 6 and 12. |
| Change from Baseline in Myeloperoxidase levels. | Weeks: 6 and 12. |
| Change from Baseline in levels of Oxidative Stress as assessed by Per-Ox-Assay. | Weeks: 6 and 12. |
| Change from Baseline in Total Cholesterol levels. | Weeks: 6 and 12. |
| Change from Baseline in Triglycerides levels. | Weeks: 6 and 12. |
| Change from Baseline in High Density Lipoprotein levels. | Weeks: 6 and 12. |
| Change from Baseline in Low Density Lipoprotein levels. | Weeks: 6 and 12. |
| Change from Baseline in Oxidized Low Density Lipoprotein levels. | Weeks: 6 and 12. |
| Change from Baseline in Soluble Intercellular Adhesion Molecule levels. | Weeks: 6 and 12. |
| Change from Baseline in Soluble Vascular Cell Adhesion Molecule levels. | Weeks: 6 and 12. |
| Change from Baseline in Osteoprotegrin levels. | Weeks: 6 and 12. |
| Change from Baseline in 11-dihydroxy-thromboxan B2 levels. | Weeks: 6 and 12. |
| Change from Baseline in Placental Growth Factor levels. | Weeks: 6 and 12. |
| Rottweil |
| Baden-Wurttemberg |
| Germany |
| Spaichingen | Baden-Wurttemberg | Germany |
| Weilersbach | Bavaria | Germany |
| Hanover | Lower Saxony | Germany |
| Cologne | North Rhine-Westphalia | Germany |
| Essen | North Rhine-Westphalia | Germany |
| Werne | North Rhine-Westphalia | Germany |
| Mainz | Rhineland-Palatinate | Germany |
| Schauenburg | Rhineland-Palatinate | Germany |
| Dresden | Saxony | Germany |
| Berlin | State of Berlin | Germany |
| Blankenhain | Thuringia | Germany |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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