Status:
COMPLETED
Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Hypertension
Eligibility:
MALE
19-65 years
Phase:
PHASE1
Brief Summary
To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00626743
Start Date
May 1 2008
End Date
July 1 2011
Last Update
April 21 2014
Active Locations (2)
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1
INJE University Pusan Paik Hospital
Pusan, South Korea
2
Asan Medical Center
Seoul, South Korea