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To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Candesartan cilexetil 16mg monotherapy |
|
| 2 | Experimental | Candesartan cilexetil 16mg/HCT combination therapy |
|
| 3 | Active Comparator | candesartan cilexetil 32mg monotherapy |
|
| 4 | Experimental | Candesartan Cilexetil 32 mg/HCT combination therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan Cilexetil | Drug | Candesartan Cilexetil 16 mg oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy | Mean of the changed DBP from baseline after 4 weeks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy | Mean of the changed SBP from baseline after 4 weeks | 4 weeks |
| Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Hoon Choi | Severance Hospital | Principal Investigator |
| Joonwoo Bahn | AstraZeneca Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21831438 | Derived | Lee HY, Hong BK, Chung WJ, Lee BK, Lee SH, Jeon DW, Ahn YK, Kim D, Park CK, Kim SH, Jung HO, Kim BO, Choi D. Phase IV, 8-week, multicenter, randomized, active treatment-controlled, parallel group, efficacy, and tolerability study of high-dose candesartan cilexetil combined with hydrochlorothiazide in Korean adults with stage II hypertension. Clin Ther. 2011 Aug;33(8):1043-56. doi: 10.1016/j.clinthera.2011.07.002. Epub 2011 Aug 10. |
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253 enrolled, 20 screening failure, 223 randomised, 198 completed
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| ID | Title | Description |
|---|---|---|
| FG000 | Candesartan Cilexetil/Hydroclorozide Combination Therapy | candesartan cilexetil/Hydroclorozide combination therapy |
| FG001 | Candesartan Cilexetil Monotherapy | candesartan cilexetil monotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Candesartan Cilexetil/Hydroclorozide Combination Therapy | candesartan cilexetil/Hydroclorozide combination therapy |
| BG001 | Candesartan Cilexetil Monotherapy | candesartan cilexetil monotherapy |
| 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 | Changes in Mean Sitting DBP From Baseline After 4 Weeks of Therapy | Mean of the changed DBP from baseline after 4 weeks | Posted | Mar 2010 | Least Squares Mean | Standard Deviation | mmHg | 4 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 Cilexetil/Hydroclorozide Combination Therapy | candesartan cilexetil/Hydroclorozide combination therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast clacifications | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1509 64589 | 4589 | 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 |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
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| Hydrochlorothiazide | Drug | Hydrochlorothiazide 12.5 mg |
|
|
| Candesartan Cilexetil | Drug | Candesartan Cilexetil 32 mg oral |
|
|
Percent of the patients achieving goal DBP and SBP after 4 weeks |
| 4 weeks |
| Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy | Percent of patients achieving goal of DBP | 8 weeks |
| Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy | Changed SBP from baseline after 8 weeks | 8 weeks |
| Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy | Change of hs-CRP from basline after 8 weeks | 8 weeks |
| Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks) | Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks | 8 weeks |
| Compliance Levels at 4 Weeks and 8 Weeks of Therapy | Percent of the number of returened pills to the number of prescrited pills | 8 weeks |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy | Mean of the changed SBP from baseline after 4 weeks | Not Posted | Least Squares Mean | mmHg | 4 weeks |
| Secondary | Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy | Percent of the patients achieving goal DBP and SBP after 4 weeks | Not Posted | Number | Participants | 4 weeks |
| Secondary | Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy | Percent of patients achieving goal of DBP | Not Posted | Number | Participants | 8 weeks |
| Secondary | Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy | Changed SBP from baseline after 8 weeks | Not Posted | Least Squares Mean | mmHg | 8 weeks |
| Secondary | Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy | Change of hs-CRP from basline after 8 weeks | Not Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
| Secondary | Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks) | Occurred number of AE and disconinuation of study medication due to the AE from basline after 8 weeks | Not Posted | Number | Participants | 8 weeks |
| Secondary | Compliance Levels at 4 Weeks and 8 Weeks of Therapy | Percent of the number of returened pills to the number of prescrited pills | Not Posted | Mean | Standard Deviation | percent | 8 weeks |
| 1 |
| 6 |
| EG001 | Candesartan Cilexetil Monotherapy | candesartan cilexetil monotherapy | 2 | 3 |
| Scrub typhus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Anal fistula | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D013457 |
| Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |