Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension

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: NCT01198249
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : March 28, 2011
Sponsor:
Information provided by:
Yonsei University

Tracking Information
First Submitted Date  ICMJE September 8, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date March 28, 2011
Study Start Date  ICMJE September 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01198249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
Official Title  ICMJE A Randomized, Open Label, Multiple Dose, Crossover Study to Investigate Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension
Brief Summary This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Essential Hypertension
Intervention  ICMJE Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study
Study Arms  ICMJE
  • Experimental: amlodipine monotherapy
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
  • Experimental: losartan monotherapy
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
  • Experimental: HCTZ
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
  • Experimental: mlodipine and Losartan and HCTZ
    Intervention: Drug: multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide
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: March 25, 2011)
23
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
28
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult subjects 20-50 years of age
  • Above 55Kg and within ±20% ideal body weight
  • Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) < 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) < 100mmHg
  • Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
  • Subjects who wrote informed consent

Exclusion Criteria:

  • Subjects who are suspected to have acute disease
  • Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
  • Subjects who have gastrointestinal history
  • Subjects whose heartrate is less than 60
  • Subject who suspected to orthostatic hypotension
  • Subjects who have clinically significant allergy disease
  • Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
  • Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
  • Subjects who have past history of drug abuse and positive in drug screening test
  • Subjects who donate whole blood within 60 days and platelet within 30days.
  • Subjects taking St John's wort or CYP inhibitor and inducer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (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 NCT01198249
Other Study ID Numbers  ICMJE 4-2010-0295
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyung-Mi Park / Director, Hanmi Pharmaceutial Co., Ltd.
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jae-Yong Chung, MD, Ph.D Severance Hospital
PRS Account Yonsei University
Verification Date March 2011

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