Hypertension
Conditions
Brief summary
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
Interventions
DRUGSK3530 100mg, Placebo, Amlodipine
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male subjects 19-65 years of age inclusive * Subjects with hypertension as defined 100 mmHg ≤ SBP\<140 mmHg and 65 mmHg ≤ DBP \< 90 mmHg after more than 5 minutes in the supine position * Written informed consent * Willing and able to comply with the requirements of the protocol
Exclusion criteria
* Subjects with acute or chronic disease within 4 weeks of study initiation. * Subejcts with any gastrointestinal disorders known to alter drug absorption(except appendectomy, herniotomy, etc.) * Subjects with any clinically significant allergic disease or with a known allergy to the PDE5 inhibitors * Subjects with clinically significant abnormalities on laboratory tests * Subjects with orthostatic hypotension defined as a fall in systolic blood pressure of at least 20 mmHg or diastolic blood pressure of at least 10 mmHg when a person assumes a standing position * Subjects with abnormal QTc interval(≥440ms) * Subjects with color-blindness or weakness * Subejcts with alcohol, drug or caffeine abuse * Diet known to alter drug absorption, distribution, metabolism or elimination processes * Subjects who participated in other clinical studies within 2 months before an administration * Other subjects who are ineligible for the study at the discretion of the principle investigator or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Change From Baseline in Standing SBP | within 8 hrs after SK3530 or placebo |
Secondary
| Measure | Time frame |
|---|---|
| Maximal Change From Baseline in Standing DBP | within 8 hrs after SK3530 or placebo |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INJE University Pusan Paik Hospital | 8 |
| Asan Medical Center | 5 |
| Total | 13 |
Baseline characteristics
| Characteristic | INJE University Pusan Paik Hospital | Asan Medical Center | Total |
|---|---|---|---|
| Age, Continuous | 48.63 years STANDARD_DEVIATION 6.93 | 54.00 years STANDARD_DEVIATION 10.56 | 50.69 years STANDARD_DEVIATION 8.52 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 12 | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Maximal Change From Baseline in Standing SBP
Time frame: within 8 hrs after SK3530 or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amlodipine + SK3530 | Maximal Change From Baseline in Standing SBP | -7.42 mmHg | Standard Deviation 5.6 |
| Amlodipine + Placebo | Maximal Change From Baseline in Standing SBP | -4.42 mmHg | Standard Deviation 5.37 |
Secondary
Maximal Change From Baseline in Standing DBP
Time frame: within 8 hrs after SK3530 or placebo
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amlodipine + SK3530 | Maximal Change From Baseline in Standing DBP | -7.17 mmHg | Standard Deviation 5.72 |
| Amlodipine + Placebo | Maximal Change From Baseline in Standing DBP | -3.50 mmHg | Standard Deviation 3.37 |