Phase 1
Completed N=13
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
Source: ClinicalTrials.gov NCT00626743 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcomePrimary: Maximal Change From Baseline in Standing SBP — -7.42; -4.42 mmHg
Summary
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Change From Baseline in Standing SBP |
-7.42; -4.42 | — |
| SECONDARY Maximal Change From Baseline in Standing DBP |
-7.17; -3.50 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00626743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.