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To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SK3530 | Experimental | Active Drug |
|
| Placebo | Placebo Comparator | Tablet which has the same appearance and taste but doesn't contain active ingredient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SK3530 100mg, Placebo, Amlodipine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Change From Baseline in Standing SBP | within 8 hrs after SK3530 or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Change From Baseline in Standing DBP | within 8 hrs after SK3530 or placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Gook Shin, MD,PhD | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INJE University Pusan Paik Hospital | Pusan | South Korea | ||||
| Asan Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | SK3530 | Active Drug SK3530 100mg, Placebo, Amlodipine |
| FG001 | Placebo | Tablet which has the same appearance and taste but doesn't contain active ingredient SK3530 100mg, Placebo, Amlodipine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| |||||||||||||
| Wash-out Period of 6 Days |
| |||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INJE University Pusan Paik Hospital | |
| BG001 | Asan Medical Center | |
| BG002 | Total |
| 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 | Maximal Change From Baseline in Standing SBP | Posted | Mean | Standard Deviation | mmHg | within 8 hrs after SK3530 or placebo |
|
|
about 6 weeks
Screening visit ~ Post-study visit
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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 | Amlodipine + SK3530 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jae Gook Shin, MD,PhD | INJE University Pusan Paik Hospital | +82-51-890-8954 | phshinjg@paik.ac.kr |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C518762 | 2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Seoul |
| South Korea |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Maximal Change From Baseline in Standing DBP | Posted | Mean | Standard Deviation | mmHg | within 8 hrs after SK3530 or placebo |
|
|
|
| 0 |
| 12 |
| 2 |
| 12 |
| EG001 | Amlodipine + Placebo | 0 | 12 | 1 | 12 |
| Flushing(facial flushing) | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Vascular Headache(headache) | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release