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This study will evaluate whether losartan protects the kidney in hypertensive Type II diabetic participants with microalbuminuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan 50 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. | ||
| Losartan 100 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Macroalbuminuria After 6 Months of Treatment | Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline. | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (SBP) | SBP at baseline and month 6. | Baseline and Month 6 |
| Diastolic Blood Pressure (DBP) | DBP at baseline and month 6. |
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Inclusion Criteria:
Exclusion criteria:
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Adult participants with diabetes mellitus and hypertension treated with losartan 50 mg or 100 mg for at least 6 months in a hospital setting in Taiwan
211 patients were enrolled in this study. Among these patients, 136 patients were eligible after excluding 75 patients.
All the medical charts of the targeted study patients were reviewed. The study index period (when patients had to have received treatment for 6 months) was from June 1st 2007 to December 31st 2008. Data were collected retrospectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan 50 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. |
| FG001 | Losartan 100 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan 50 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. |
| BG001 | Losartan 100 mg |
| 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 | Number of Participants With Macroalbuminuria After 6 Months of Treatment | Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline. | Posted | Number | participants | Baseline and Month 6 |
|
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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 | Losartan 50 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline and Month 6 |
Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Systolic Blood Pressure (SBP) | SBP at baseline and month 6. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| Secondary | Diastolic Blood Pressure (DBP) | DBP at baseline and month 6. | Posted | Mean | Standard Deviation | mmHg | Baseline and Month 6 |
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| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Losartan 100 mg | Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008. | 0 | 37 | 0 | 37 |
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Change from Baseline at Month 6 (n=72; n=22) |
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| Change from Baseline at Month 6 (n=72; n=22) |
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