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The purpose of this study is to compare the effects of a direct renin inhibitor (DRI), aliskiren, on the urinary albumin excretion in hypertensive patients with type 2 diabetes under strict blood pressure control with angiotensin receptor blocker (ARB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct renin inhibitor | Active Comparator |
| |
| Angiotensin receptor blockers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren | Drug | The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Albuminuria | Change in the urinary albumin to creatinine ratio (UACR) from the baseline | baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Urinary Angiotensinogen Level | Change in the urinaryurinary angiotensinogen level from the baseline | baseline and 24 weeks |
| Change in the Plasma Renin Activity | baseline and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroshi Maegawa, M.D. | Shiga University of Medical Science | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiga University of Medical Science | Ōtsu | Shiga | 520-2192 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct Renin Inhibitor | Aliskiren: A total of 119 patients were randomly assigned to receive direct renin inhibitor. Eight patients dropped out during the observation period and a total of 111 patients were studied in this group. |
| FG001 | Angiotensin Receptor Blockers | A total of 118 patients were randomly assigned to receive angiotensin receptor blockers. Four patients dropped out during the observation period and a total of 114 patients were studied in this group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Renin Inhibitor | Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Reduction in Albuminuria | Change in the urinary albumin to creatinine ratio (UACR) from the baseline | Posted | Mean | 95% Confidence Interval | percentage of UACR change | baseline and 24 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 | Direct Renin Inhibitor | Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. 378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steering Committee: Takashi Uzu | Shiga University of Medical Science | 81-77-548-2222 | takuzu@belle.shiga-med.ac.jp |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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|
| any angiotensin receptor blockers | Drug | The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. |
|
| Change in the Serum Insulin Level | baseline and 24 weeks |
| BG001 | Angiotensin Receptor Blockers | any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Angiotensin Receptor Blockers | any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group. |
|
|
| Secondary | Change in the Urinary Angiotensinogen Level | Change in the urinaryurinary angiotensinogen level from the baseline | Posted | Mean | 95% Confidence Interval | percentage of change UATGCR | baseline and 24 weeks |
|
|
|
| Secondary | Change in the Plasma Renin Activity | Not Posted | baseline and 24 weeks | Participants |
| Secondary | Change in the Serum Insulin Level | Not Posted | baseline and 24 weeks | Participants |
| 0 |
| 119 |
| 0 |
| 119 |
| 2 |
| 119 |
| EG001 | Angiotensin Receptor Blockers | any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose. 378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group. | 0 | 118 | 0 | 118 | 2 | 118 |
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| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |