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| ID | Type | Description | Link |
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| CAP |
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The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candesartan | Experimental | Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan | Drug | 16 mg once daily in oral tablet form |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change of B Type Natriuretic Peptides (BNP) Level | Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used. | At Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index | Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area. | At Baseline and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JeeWoong Son, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Busan | South Korea | ||||
| Research Site |
Screening period: Laboratory test (Creatinine, potassium, ALT, etc)
Milestone date: 15 June 2006 (FSI) ~ 05 June 2008 (LSLV) Type of location: General Hospital; 333 subjects enrolled, but 18 subjects failed to be randomized, 315 subjects were randomized to study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan | Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Candesartan | Drug | 32 mg once daily in oral tablet form |
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| Felodipine | Drug | 5 mg once daily in oral tablet form |
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| Felodipine | Drug | 10 mg once daily in oral tablet form |
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| Change of Systolic Blood Pressure (SBP) | Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward. | At Baseline and 24 weeks |
| Change of Diastolic Blood Pressure (DBP) | Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward. Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data. | At Baseline and 24 weeks |
| Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only | Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward. | At Baseline and 24 weeks |
| Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine | Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward. | At Baseline and 24 weeks |
| Cheonan |
| South Korea |
| Research Site | Cheongju-si | South Korea |
| Research Site | Chunbuk | South Korea |
| Research Site | Daegu | South Korea |
| Research Site | Daejeon | South Korea |
| Research Site | Gyungsangnamdo | South Korea |
| Research Site | Jeonju | South Korea |
| Research Site | Kwangju | South Korea |
| Research Site | Pusan | South Korea |
| Research Site | Ulsan | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Candesartan |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percent Change of B Type Natriuretic Peptides (BNP) Level | Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used. | Followed Intent-to-treat analysis | Posted | Median | Full Range | Percent Change | At Baseline and 24 weeks |
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| Secondary | LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index | Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area. | Only 245 patients who have reliable Echocardiac data were analyzed. | Posted | Median | Full Range | g/m^2 | At Baseline and 24 weeks |
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| Secondary | Change of Systolic Blood Pressure (SBP) | Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward. | Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data. | Posted | Median | Full Range | mmHg | At Baseline and 24 weeks |
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| Secondary | Change of Diastolic Blood Pressure (DBP) | Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward. Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data. | Last Observational carried forward | Posted | Median | Full Range | mmHg | At Baseline and 24 weeks |
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| Secondary | Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only | Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward. | Only 201 patients are available for analysis. | Posted | Median | Full Range | percent change | At Baseline and 24 weeks |
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| Secondary | Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine | Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward. | Only 91 patients are available for analysis | Posted | Median | Full Range | percent change | At 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 | Candesartan | 8 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left paraduodenal hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Rectal prolapse aggravated | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebral infarction | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Uterine myoma aggravated | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Cervical disc herniation aggravated | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia with effusion in the right chest | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Granuloma inguinale | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C081643 | candesartan |
| C077793 | candesartan cilexetil |
| D015736 | Felodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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