NCT02387619

Brief Summary

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 24, 2016

Status Verified

March 1, 2015

Enrollment Period

28 days

First QC Date

March 9, 2015

Last Update Submit

June 23, 2016

Conditions

HypertensionHyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine

    72hours, 144hours

Secondary Outcomes (8)

  • AUClast,ss of Rosuvastatin

    72hours

  • AUCinf,ss of Rosuvastatin

    72hours

  • Tmax,ss of Rosuvastatin

    72hours

  • t1/2 of Rosuvastatin

    72hours

  • AUClast,ss of Telmisartan, Amlodipine

    144hours

  • +3 more secondary outcomes

Study Arms (4)

Group 1 of part 1

EXPERIMENTAL

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T during the period 1 and Rosuvastatin 20mg 1T and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Drug: RosuvastatinDrug: Rosuvastatin and Telmisartan/Amlodipine

Group 2 of part 1

EXPERIMENTAL

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T during the period 2

Drug: Telmisartan/AmlodipineDrug: Rosuvastatin and Telmisartan/Amlodipine

Group 1 of part 2

EXPERIMENTAL

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 2

Drug: RosuvastatinDrug: Rosuvastatin and Telmisartan/Amlodipine

Group 2 of part 2

EXPERIMENTAL

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin 20mg 1T, Telmisartan/Amlodipine 40/5mg 2T during the period 1 and Telmisartan/Amlodipine 40/5mg 2T during the period 2

Drug: Telmisartan/AmlodipineDrug: Rosuvastatin and Telmisartan/Amlodipine

Interventions

RosuvastatinDRUG

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days

Also known as: Crestor
Group 1 of part 1Group 1 of part 2
Telmisartan/AmlodipineDRUG

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days

Also known as: Twynsta
Group 2 of part 1Group 2 of part 2
Rosuvastatin and Telmisartan/AmlodipineDRUG

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days

Also known as: Crestor and Twynsta
Group 1 of part 1Group 1 of part 2Group 2 of part 1Group 2 of part 2

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \~55 years healthy male
  • Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
  • Subjects who agree to keep contraceptive methods during the clinical trial.

You may not qualify if:

  • Subjects who are allergic to investigational drug.
  • Subjects who have a medical history which can affect the clinical trial.
  • Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
  • Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System

Seoul, Seodaemun-gu, 120-752, South Korea

Location

MeSH Terms

Conditions

HypertensionHyperlipidemias

Interventions

Rosuvastatin Calciumtelmisartan amlodipine combinationTelmisartanAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDihydropyridinesPyridines

Study Officials

  • Kyungsoo Park, MD, Ph.D.

    Yonsei University

    PRINCIPAL INVESTIGATOR

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

March 9, 2015

First Posted

March 13, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

June 24, 2016

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)