NCT01197014

Brief Summary

Study Design : \- A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 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

September 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 27, 2011

Status Verified

April 1, 2011

Enrollment Period

2 months

First QC Date

September 7, 2010

Last Update Submit

April 26, 2011

Conditions

Healthy

Keywords

Amlodipine, Losartan

Outcome Measures

Primary Outcomes (1)

  • AUC, Cmax

    0-144hrs

Study Arms (2)

Amlodipine plus Losartan

EXPERIMENTAL
Drug: Amlodipine plus Losartan

Amlodipine, Losartan

ACTIVE COMPARATOR
Drug: Amlodipine, Losartan

Interventions

Amlodipine plus LosartanDRUG

Amlodipine/Losartan high dose

Amlodipine plus Losartan
Amlodipine, LosartanDRUG

Amlodipine, Losartan

Amlodipine, Losartan

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55 years
  • Healthy Caucasian volunteers
  • Non smokers or mild smokers

You may not qualify if:

  • Pregnancy and/or breast-feeding
  • Participation in another clinical trial within 60 days prior to Period 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEPHA s.r.o.

Pilsen, Czechia

Location

MeSH Terms

Interventions

AmlodipineLosartanamlodipine-losartan drug combination

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesTetrazoles

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

April 27, 2011

Record last verified: 2011-04

Locations

CZ(1)