Trial Outcomes & Findings for Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin (NCT NCT01422382)

NCT ID: NCT01422382

Last Updated: 2012-07-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: 15 Days
• Results posted on: 2012-07-13

Participant Flow

1st Subject Enrolled 05 May 2011, Last Subject Completed 12 July 2011 at PPD Inc. 7551 Metro Center Drive Suite 200 Austin, TX 78744

Participant milestones

Measure	All Subjects All randomized subjects.
NK-104 4mg Once Daily (QD) STARTED	28
NK-104 4mg Once Daily (QD) COMPLETED	28
NK-104 4mg Once Daily (QD) NOT COMPLETED	0
Diltiazem 240 mg QD STARTED	28
Diltiazem 240 mg QD COMPLETED	28
Diltiazem 240 mg QD NOT COMPLETED	0
NK-104 4mg QD and Diltiazem 240 mg QD STARTED	28
NK-104 4mg QD and Diltiazem 240 mg QD COMPLETED	27
NK-104 4mg QD and Diltiazem 240 mg QD NOT COMPLETED	1

Reasons for withdrawal

Measure	All Subjects All randomized subjects.
NK-104 4mg QD and Diltiazem 240 mg QD personal reasons	1

Baseline Characteristics

Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin

Baseline characteristics by cohort

Measure	All Subjects n=28 Participants All randomized subjects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	29.2 years STANDARD_DEVIATION 7.63 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 Days

Population: All subjects with measurable pharmacokinetic (PK) values

Outcome measures

Measure	All Subjects n=26 Participants All randomized subjects.
NK-104 AUC	208.92 ng * h/mL Standard Deviation 86.54

SECONDARY outcome

Timeframe: 24 Days

Outcome measures

Measure	All Subjects n=28 Participants All randomized subjects.
Number of Participants With at Least One Adverse Event.	12 Participants

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Subjects n=28 participants at risk All randomized subjects.
Nervous system disorders Headache	17.9% 5/28
Nervous system disorders Presyncope	10.7% 3/28
Infections and infestations Nasopharyngitis	7.1% 2/28
Respiratory, thoracic and mediastinal disorders Cough	7.1% 2/28

Additional Information

Roger Morgan, MD FACS

Kowa Research Institute, Inc

Phone: 919-433-1600

Email: RMorgan@kowaus.com

Results disclosure agreements

• Principal investigator is a sponsor employee May not publish.
• Publication restrictions are in place

Restriction type: OTHER