Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: SK3530 100mg, Placebo, Amlodipine

• Registration Number: NCT00626743
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

To assess the pharmacodynamic effects of co-administrated SK3530 (PDE5 inhibitor) and Amlodipine, phase I study in Hypertensive patient was designed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-21
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Study Start: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2011-07
• Status Verified: 2014-03
• Results First Submitted: 2014-03-13
• Results First Submitted QC: 2014-03-13
• Last Update Submitted: 2014-03-13
• Results First Posted: 2014-04-21
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SK3530	SK3530 100mg, Placebo, Amlodipine	Active Drug
Placebo	SK3530 100mg, Placebo, Amlodipine	Tablet which has the same appearance and taste but doesn't contain active ingredient

Primary Outcome Measures

Name	Time	Method
Maximal Change From Baseline in Standing SBP	within 8 hrs after SK3530 or placebo

Secondary Outcome Measures

Name	Time	Method
Maximal Change From Baseline in Standing DBP	within 8 hrs after SK3530 or placebo

Trial Locations

Locations (2)

INJE University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of