NCT01148368

Brief Summary

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 9, 2012

Status Verified

December 1, 2010

Enrollment Period

1 month

First QC Date

June 21, 2010

Last Update Submit

January 6, 2012

Conditions

Renal Impairment

Keywords

fimasartanrenal impairmenthypertension

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic characteristic of fimasartan

    AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan

    0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h

Study Arms (2)

renal impairment patients

EXPERIMENTAL

renal impairment patients who eGFR is lower than 30 ml/min/1.73m\^2 without hemodialysis

Drug: fimasartan

healthy volunteers

ACTIVE COMPARATOR

healthy volunteers group

Drug: fimasartan

Interventions

fimasartanDRUG

single administration of fimasartan 120mg

healthy volunteersrenal impairment patients

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<Renal impairment patient\>
  • age: 20-65 years
  • eGFR: \< 30ml/min/1.73m\^2
  • not on dialysis
  • body weight: greater than 55kg
  • written informed consent
  • \<Healthy volunteer\>
  • age: 20-65 years
  • body weight: greater than 55kg
  • written informed consent

You may not qualify if:

  • AST, ALT \> 1.5 times of upper normal range
  • positive drug or alcohol screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal InsufficiencyHypertension

Interventions

fimasartan

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yon Su Kim, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2011

Last Updated

January 9, 2012

Record last verified: 2010-12

Locations

KR(1)