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A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin Group | Experimental |
| |
| Atorvastatin Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Achieving LDL- C<100mg/dL | compare the proportion of patients achieving LDL- C<100mg/dL | After 16wk drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of LDL-C | The change of LDL-C between at 16-week and baseline | After 16wk drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho Young Shon, MD | Endocrinology, Kangnam Saint Mary's Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin Group | Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks |
| FG001 | Atorvastatin Group | Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin Group | Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks |
| BG001 | Atorvastatin Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Achieving LDL- C<100mg/dL | compare the proportion of patients achieving LDL- C<100mg/dL | Posted | Count of Participants | Participants | No | After 16wk drug administration |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pitavastatin Group | Pitavastatin: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hoyoung Sohn | CMC | 82-2-222-2222 | 3333 | abc@snu.ac.kr |
| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Atorvastatin | Drug | Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks |
|
|
Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Change of LDL-C | The change of LDL-C between at 16-week and baseline | Posted | Mean | Standard Deviation | mg/dl | After 16wk drug administration |
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 3 |
| 81 |
| EG001 | Atorvastatin Group | Atorvastatin: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C <100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks | 0 | 70 | 0 | 70 | 0 | 70 |
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |