Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000277741
Ethics application status
Approved
Date submitted
4/03/2013
Date registered
7/03/2013
Date last updated
7/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I, Open-Label, Pharmacokinetic Study of ivabradine in healthy Chinese volunteers
Scientific title
A Phase 1, Open Label, Single-Center, Dose-increasing Study to Determine the Safety and Pharmacokinetics of Single and Repeated oral administration of ivabradine in Healthy Chinese Volunteers
Secondary ID [1] 282065 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Stable Angina Pectoris 288552 0
Condition category
Condition code
Cardiovascular 288881 288881 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All volunteers were randomly assigned, using a computer generated table of random numbers, to 3 treatment groups of ivabradine: 5, 10, 20mg. After a 10-hour overnight fast, volunteers received a single dose of ivabradine orally at approximately 8 a.m. on the following morning (day 1) with 200mL water. 3 days after single dose, volunteers of all three group received repeated oral doses of ivabradine (same as respective single dose) twice daily at 8 a.m and 8 p.m. for 6 consecutive days.
Intervention code [1] 286663 0
Treatment: Drugs
Comparator / control treatment
no treatment. The first group received ivabradine 5mg treatment, the second group received ivabradine 10mg treatment and the third group received ivabradine 20mg treatment. All 3 treatment groups would have equal weight in this study.
Control group
Dose comparison

Outcomes
Primary outcome [1] 289011 0
pharmacokinetics
Timepoint [1] 289011 0
Blood will be sampled pre-dose, and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h after dose for single dose and the last repeated dose
Secondary outcome [1] 301560 0
Safety: Adverse events(including visual disturbance (visual flashes, streak of light, sensation of stroboscopic vision), headach,dizziness, bradycardia,Ventricular extrasystoles), clinical laboratory data(i.e., serum chemistry, hematology and urinalysis), vital signs, electrocardiogram (ECG), ventilation status, physical exam. Adverse events(AEs) were monitored throughout the study based on spontaneous reports by volunteers, questioning by investigators, physical examinations, ECG results, vital signs and clinical test analysis. And the AE information was recorded throughout the study in terms of intensity (mild, moderate, or severe), duration, outcome, and relationship to the study drug.
Timepoint [1] 301560 0
Physical examinations and routine laboratory profiles (i.e., serum chemistry, hematology and urinalysis) were performed before the first single dose, before the 5th repeated dose and 24 after the last repeated dose. Holter (24h dynamic electrocardiogram) monitoring was performed on the screening visit, day1 (single dose) and day 8 (steady state). Systolic and diastolic blood pressure (SBP and DBP, respectively), heart rate (HR) were measured before and 2 hours after each administration as well as 6,12, 24 hours after single dose and 24, 48 hours after the last repeated dose. ECGs were performed before each administration as well as 4 hours after the morning dose from day 3 to day 8. Ophthalmologic examinations were performed before the first single dose and 24 hour after the last repeated dose. Volunteers were instructed to come back for a safety evaluation on vital signs and physical examinations 1 week after the last blood sample was collected.

Eligibility
Key inclusion criteria
Body mass index between 19 and 24 kg/m^2, nonsmokers, thorax radiography and electrocardiography without abnormalities, normal values of BP and heart rate and laboratory test results(hematology, blood biochemistry, hepatic function, and urinalysis), negative results on HIV and hepatitis types B and C testing.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. weight less than 50kg , weight index less than 19 or weight index more than 24
2.low blood pressure
3.bradycardia,sinus arrest, sinoatrial block, atrioventricular block, ectopic rhythm Holter monitoring ;
4.disease or disorders in hepatic, renal, respiratory, immune system and nervous system;
5.alcohol or drug abuse;
6.clinical significant allergies to drug or foods;
7.use of prescription or over-the-counter medication including herbal products within 4 weeks before study initiation;
8.donate blood or participated in other clinical trials within 3 months before enrollment in the study
9.positive results on HIV and hepatitis types B and C testing
10.abnormalities in laboratory test(hematology, blood biochemistry, hepatic function, and urinalysis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be assigned to one of the three dose group in accordance with the randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 286839 0
Hospital
Name [1] 286839 0
Fuwai hospital
Country [1] 286839 0
China
Funding source category [2] 286840 0
Commercial sector/Industry
Name [2] 286840 0
Jiangsu Hengrui Medicine Co,. Ltd
Country [2] 286840 0
China
Primary sponsor type
Commercial sector/Industry
Name
Jiangsu Hengrui Medicine Co,. Ltd
Address
east people road 145#, xinpu district, Lianyungang, 222047
Country
China
Secondary sponsor category [1] 285630 0
Hospital
Name [1] 285630 0
Fuwai hospital
Address [1] 285630 0
beilishi road 167#, xicheng district, Beijing, 100037
Country [1] 285630 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288905 0
the ethics and research committees in Fuwai hospital
Ethics committee address [1] 288905 0
beilishi road 167#, xicheng district, Beijing, 100037
Ethics committee country [1] 288905 0
China
Date submitted for ethics approval [1] 288905 0
Approval date [1] 288905 0
12/06/2010
Ethics approval number [1] 288905 0

Summary
Brief summary
The purpose of this study is to explore the pharmacokinetic property as well as the safety and tolerance of ivabradine in Chinese healthy volunteers and provide important information for phase II study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38286 0
Prof Shuang Xie
Address 38286 0
beilishi road 167#, xicheng district, Beijing, 100037
Country 38286 0
China
Phone 38286 0
8610-68331753
Fax 38286 0
Email 38286 0
lchyl_fuwai@sina.com
Contact person for public queries
Name 38287 0
Prof Lei Tian
Address 38287 0
beilishi road 167#, xicheng district, Beijing, 100037
Country 38287 0
China
Phone 38287 0
8610-88398547
Fax 38287 0
Email 38287 0
tianlei0807@hotmail.com
Contact person for scientific queries
Name 38288 0
Prof Lei Tian
Address 38288 0
beilishi road 167#, xicheng district, Beijing, 100037
Country 38288 0
China
Phone 38288 0
8610-88398547
Fax 38288 0
Email 38288 0
tianlei0807@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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