NCT02608242

Brief Summary

This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
123

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Nov 2015

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

November 11, 2015

Last Update Submit

January 31, 2017

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (6)

  • Telmisartan Cmax

    0 - 72 hrs

  • Telmisartan AUClast

    0 - 72 hrs

  • Amlodipine Cmax

    0 - 168 hrs

  • Amlodipine AUClast

    0 - 168 hrs

  • Rosuvastatin Cmax

    0 - 48 hrs

  • Rosuvastatin AUClast

    0 - 48 hrs

Study Arms (3)

YH22189

EXPERIMENTAL

YH22189 FDC tablet of Yuhan Corporation

Drug: YH22189

Twynsta 80/10mg

ACTIVE COMPARATOR

Telmisartan/Amlodipine 80/10mg (FDC)

Drug: Twynsta 80/10mg

Crestor 20mg

ACTIVE COMPARATOR

Rosuvastatin 20mg

Drug: Crestor 20mg

Interventions

YH22189DRUG
YH22189
Twynsta 80/10mgDRUG
Also known as: Telmisartan/Amlodipine 80/10mg(FDC)
Twynsta 80/10mg
Crestor 20mgDRUG
Also known as: Rosuvastatin 20mg
Crestor 20mg

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
  • Who has not suffered from clinically significant disease
  • Provision of signed written informed consent

You may not qualify if:

  • History of and clinically significant disease
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 3 months prior to the first dosing
  • Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
  • Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonbuk National University Hospital

Jeonju, 561-712, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

telmisartan amlodipine combinationTelmisartanAmlodipineRosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2015

First Posted

November 18, 2015

Study Start

November 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)