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To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan 80mg & Rosuvastatin 20mg | Experimental | PO, Once Daily, 8 weeks |
|
| Telmisartan 80mg & Rosuvastatin 10mg | Experimental | PO, Once Daily, 8weeks |
|
| Telmisartan placebo & Rosuvastatin 20mg | Active Comparator | PO, Once Daily, 8 weeks |
|
| Telmisartan Placebo & Rosuvastatin 10mg | Active Comparator | PO, Once Daily, 8 weeks |
|
| Telmisartan 80mg & Rosuvastatin placebo | Active Comparator | PO, Once Daily, 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan 80mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| •Change in seated diastolicblood pressure at 8 weeks compared to the base value | at the 8 weeks | |
| Change in LDL-Cat 8 weeks compared to the base value (% change) | at the 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in seateddiastolic blood pressure | at 2,4 8 weeks | |
| Change in seated systolic blood pressure | at 2,4,8weeks | |
| Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Saint Mary's Hosiptal | Recruiting | Seoul | South Korea |
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| Telmisartan placebo & Rosuvastatin placebo | Placebo Comparator | PO, Once Daily, 8 weeks |
|
| Rosuvastatin 20mg | Drug |
|
| Rosuvastatin 10mg | Drug |
|
| Placebo(for Telmisartan 80mg) | Drug |
|
| Placebo(for Rosuvastatin 20mg) | Drug |
|
| Placebo(for Rosuvastatin 10mg) | Drug |
|
| at 2, 4 and 8 weeks |
| Change in LDL-Cat compared to the base value (% change) | 2, 4 and 8 weeks |
| Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change) | at 2, 4 and 8 weeks |
| Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL) | at 2, 4 and 8 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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