NCT02951962

Brief Summary

This is a phase 1, open label, two-cohort, single-sequence, crossover study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1 hypertension

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

August 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

1 month

First QC Date

August 21, 2016

Last Update Submit

January 31, 2017

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (2)

  • Telmisartan, Amlodipine, Rosuvastatin AUCτ

    0 - 24 hr

  • Telmisartan, Amlodipine, Rosuvastatin Cmax

    0 - 24 hr

Secondary Outcomes (2)

  • Telmisartan, Amlodipine, Rosuvastatin Tmax

    0 - 24 hr

  • Telmisartan, Amlodipine, Rosuvastatin Cmin

    0 - 24 hr

Study Arms (2)

Twynsta 80/5mg

EXPERIMENTAL

Day 1 \~ Day 9 : Twynsta 80/5mg / Day 10 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Drug: Twynsta 80/5mgDrug: Crestor 20mg

Crestor 20mg

EXPERIMENTAL

Day 1 \~ Day 5 : Crestor 20mg / Day 6 \~ Day 14 : Twynsta 80/5mg + Crestor 20mg

Drug: Twynsta 80/5mgDrug: Crestor 20mg

Interventions

Twynsta 80/5mgDRUG

Hypertension

Also known as: Telmisartan/Amlodipine 80/5mg
Crestor 20mgTwynsta 80/5mg
Crestor 20mgDRUG

Hyperlipidemia

Also known as: Rosuvastatin 20mg
Crestor 20mgTwynsta 80/5mg

Eligibility Criteria

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

You may qualify if:

  • Healthy male with body mass index(BMI) between 18.5 and 28 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 due to reasons including laboratory test results, ECGs, or vital signs
  • Sitting blood pressure meeting the following criteria at screening: 160 ≥ systolic blood pressure ≤100 (mmHg) and 95 ≥ 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 Officials

  • Min-Gul Kim

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 21, 2016

First Posted

November 1, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)