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A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02122939
Recruitment Status : Completed
First Posted : April 25, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Jae Yong Chung, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2014
First Posted Date  ICMJE April 25, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE September 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F [ Time Frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02122939 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2014)
QTc interval [ Time Frame: pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers
Official Title  ICMJE An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers
Brief Summary An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Escitalopram
Study Arms  ICMJE Experimental: Escitalopram
Intervention: Drug: Escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2014)
12
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy subject aged 65 or older at screening
  • A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
  • subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

  • subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
  • Subject judged not eligible for study participation by investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02122939
Other Study ID Numbers  ICMJE ECTE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae Yong Chung, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Yong Chung, MD, PhD Seoul National University Bundang Hospital, Seongnam, Korea
PRS Account Seoul National University Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP