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| Name | Class |
|---|---|
| Kyungpook National University Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
| Keimyung University | OTHER |
| Kosin University Gospel Hospital |
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The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.
A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.
During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fimasartan 60mg | Active Comparator | Take one tablet of Fimasartan 60mg once a day in the morning |
|
| Fimasartan 120mg | Active Comparator | Take one tablet of Fimasartan 120mg once a day in the morning |
|
| Candesartan 8mg | Active Comparator | Take one tablet of Candesartan 8mg once a day in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fimasartan 60mg | Drug | Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sitting Diastolic Blood Pressure | To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg | 12weeks from baseline visit |
| Measure | Description | Time Frame |
|---|---|---|
| Sitting DBP | To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg | at 12weeks from Baseline visit |
| SittingDBP | To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ShungChull Chae, Doctor´s degree | KuyngPook National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KyungPook National University Hospital | Daegu | Daegu | 110-750 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27161546 | Derived | Lee JH, Yang DH, Hwang JY, Hur SH, Cha TJ, Kim KS, Kim MH, Chun KJ, Cha GS, Hong GR, Lee SG, Kim DS, Kim DI, Chae SC. A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension. Clin Ther. 2016 Jun;38(6):1485-1497. doi: 10.1016/j.clinthera.2016.04.005. Epub 2016 May 6. | |
| 21740078 |
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| OTHER |
| Daegu Catholic University Medical Center | OTHER |
| Dong-A medical center | UNKNOWN |
| Pusan National University Yangsan Hospital | OTHER |
| Yeungnam University Hospital | OTHER |
| Ulsan University Hospital | OTHER |
| Inje University | OTHER |
| Pusan National University Hospital | OTHER |
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| Fimasartan 120mg | Drug | Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning. |
|
| Candesartan cilexetil | Drug | Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning. |
|
|
| at 4, 8 weeks from baseline visit |
| Sitting Systolic Blood Pressure | To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg | at 4,8,12 weeks from baseline visit |
| Responder ratio | To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg | at 12weeks from baseline visit |
| Derived |
| Fimasartan. Am J Cardiovasc Drugs. 2011 Aug 1;11(4):249-52. doi: 10.2165/11533640-000000000-00000. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| C077793 | candesartan cilexetil |
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