Trial Outcomes & Findings for Phase I Study to Investigate the Effect on the Blood Pressure After Oral Administration of SK3530 and Amlodipine (NCT NCT00626743)

NCT ID: NCT00626743

Last Updated: 2014-04-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 13 participants
• Primary outcome timeframe: within 8 hrs after SK3530 or placebo
• Results posted on: 2014-04-21

Participant Flow

Participant milestones

Measure	SK3530 Active Drug SK3530 100mg, Placebo, Amlodipine	Placebo Tablet which has the same appearance and taste but doesn't contain active ingredient SK3530 100mg, Placebo, Amlodipine
Treatment Period 1 STARTED	6	7
Treatment Period 1 COMPLETED	6	6
Treatment Period 1 NOT COMPLETED	0	1
Wash-out Period of 6 Days STARTED	6	6
Wash-out Period of 6 Days COMPLETED	6	6
Wash-out Period of 6 Days NOT COMPLETED	0	0
Treatment Period 2 STARTED	6	6
Treatment Period 2 COMPLETED	6	6
Treatment Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	INJE University Pusan Paik Hospital n=8 Participants	Asan Medical Center n=5 Participants	Total n=13 Participants Total of all reporting groups
Age, Continuous	48.63 years STANDARD_DEVIATION 6.93 • n=93 Participants	54.00 years STANDARD_DEVIATION 10.56 • n=4 Participants	50.69 years STANDARD_DEVIATION 8.52 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants

PRIMARY outcome

Timeframe: within 8 hrs after SK3530 or placebo

Outcome measures

Measure	Amlodipine + SK3530 n=12 Participants	Amlodipine + Placebo n=12 Participants
Maximal Change From Baseline in Standing SBP	-7.42 mmHg Standard Deviation 5.60	-4.42 mmHg Standard Deviation 5.37

SECONDARY outcome

Timeframe: within 8 hrs after SK3530 or placebo

Outcome measures

Measure	Amlodipine + SK3530 n=12 Participants	Amlodipine + Placebo n=12 Participants
Maximal Change From Baseline in Standing DBP	-7.17 mmHg Standard Deviation 5.72	-3.50 mmHg Standard Deviation 3.37

Adverse Events

Amlodipine + SK3530

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Amlodipine + Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Amlodipine + SK3530 n=12 participants at risk	Amlodipine + Placebo n=12 participants at risk
Cardiac disorders Dizziness	0.00% 0/12 • about 6 weeks Screening visit \~ Post-study visit	8.3% 1/12 • Number of events 1 • about 6 weeks Screening visit \~ Post-study visit
Vascular disorders Flushing(facial flushing)	8.3% 1/12 • Number of events 1 • about 6 weeks Screening visit \~ Post-study visit	0.00% 0/12 • about 6 weeks Screening visit \~ Post-study visit
Vascular disorders Vascular Headache(headache)	8.3% 1/12 • Number of events 1 • about 6 weeks Screening visit \~ Post-study visit	0.00% 0/12 • about 6 weeks Screening visit \~ Post-study visit

Additional Information

Jae Gook Shin, MD,PhD

INJE University Pusan Paik Hospital

Phone: +82-51-890-8954

Email: phshinjg@paik.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
• Publication restrictions are in place

Restriction type: OTHER