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To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Candesartan Cilexetil |
|
| 2 | Experimental | Candesartan Cilexetil |
|
| 3 | Experimental | Candesartan Cilexetil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan Cilexetil | Drug | 8 mg oral once daily dose |
|
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| Measure | Description | Time Frame |
|---|---|---|
| The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks | Decrease of urinary protein/creatinine ratio means improvement of renal disease. | baseline to 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Systolic and Diastolic Blood Pressure From Baseline | baseline to 28 weeks | |
| Inflammatory Marker (Hs-C-peptide Reactive Protein) | To evaluate how to reduce and relate with cardiovascular risk |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Da Suk Han | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Seoul | South Korea |
Total 128 patient enrolled, but among of them, 9 subjects excluded from analysis because of Withdrawal by Subject, Protocol violation, Eligibility criteria not fullfiled. You can see these number in above table. This analysis was conducted based on Intend to treat. Therefore, total analyzed number is 119, and 39, 44, 36 per arm respectively.
155 enrolled, 27 screening failure, 128 randomized. Eligibility criteria not fulfilled meant subjects who were not fulfilled at Visit 1 or Enrolment, but screening failure subjects were who fulfilled at Visit 1, but not at Visit 2 after screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan 8 mg | Candesartan 8 mg oral once daily dose |
| FG001 | Candesartan 16mg | Candesartan 16mg oral once daily dose |
| FG002 | Candesartan 32mg | Candesartan 32mg oral once daily dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Candesartan 8 mg | Candesartan 8 mg oral once daily dose |
| BG001 | Candesartan 16mg | Candesartan 16mg oral once daily dose |
| 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 | The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks | Decrease of urinary protein/creatinine ratio means improvement of renal disease. | Posted | Apr 2010 | Mean | Standard Deviation | mg/g | baseline to 28 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 | Candesartan 8 mg | Candesartan 8 mg oral once daily dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 7780 956181 | 5895 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C077793 | candesartan cilexetil |
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| Candesartan Cilexetil | Drug | 16 mg oral once daily dose |
|
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| Candesartan Cilexetil 32mg | Drug | 32 mg oral once daily dose |
|
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| baseline to 28 weeks |
| Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation | GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units) | 28 weeks |
| Treatment-emergent Adverse Events | Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product. | Baseline to 28 weeks |
| Withdrawal by Subject |
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| Protocol Violation |
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| Eligibility criteria not fulfilled |
|
| BG002 | Candesartan 32mg | Candesartan 32mg oral once daily dose |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Analyzed efficacy data and demography data based on Intended to Treat (ITT) set. The discrepancy of "Total" and "Started Period 1" is who is excluded to the ITT set. | Number | Participants |
|
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| Secondary | Change of Systolic and Diastolic Blood Pressure From Baseline | Posted | Apr 2010 | Mean | Standard Deviation | mmHg | baseline to 28 weeks |
|
|
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| Secondary | Inflammatory Marker (Hs-C-peptide Reactive Protein) | To evaluate how to reduce and relate with cardiovascular risk | Posted | Apr 2010 | Mean | Standard Deviation | mg/dL | baseline to 28 weeks |
|
|
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| Secondary | Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation | GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units) | Posted | Apr 2010 | Mean | Standard Deviation | mL/min/1.73 m2 | 28 weeks |
|
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| Secondary | Treatment-emergent Adverse Events | Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product. | Posted | Apr 2010 | Number | Participants | Baseline to 28 weeks |
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| 0 |
| 40 |
| 11 |
| 40 |
| EG001 | Candesartan 16mg | Candesartan 16mg oral once daily dose | 1 | 45 | 6 | 45 |
| EG002 | Candesartan 32mg | Candesartan 32mg oral once daily dose | 1 | 43 | 9 | 43 |
| Acute leukaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Pnuemonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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