Recent Updates
Recently added Catalysts

Reference Treatment: 1 x amlodipine and 1 x losartan administered in

Phase 1

Hypertension | Small molecule | Cardiovascular |GSK plc|Last Updated: Jul 26, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

Reference Treatment: 1 x amlodipine and 1 x losartan administered in · 1 trial · 1 indication

Phase 1 1
NCT01648231Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health VolunteersHypertension
COMPLETED23 Analytics
PHASE1COMPLETED
Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers
Hypertension
NCT0164823123
Unlock trial analytics

Study Endpoints

Primary Endpoints

Plasma concentration of amlodipine and losartan: Peak plasma concentration (Cmax) and last measurable plasma concentration (Clast)
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks

Comparison of Cmax and Clast after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)

Time to peak plasma concentration (Tmax) of amlodipine and losartan
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks

Comparison of Tmax after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)

Area under the plasma concentration-time curve (AUC) of amlodipine and losartan: from time zero to time t (AUCt), from time zero to infinity (AUCinf) and time t to infinity as a percentage of total AUC (%AUCex)
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks

Comparison of AUCt, AUCinf and %AUCex after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)

Elimination half-life (t½) of amlodipine and losartan
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks

Comparison of t½ after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)

Secondary Endpoints

Number of healthy volunteers with adverse events
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Plasma concentration of of carboxylic acid: Peak plasma concentration (Cmax)
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Elimination half-life (t½) of carboxylic acid
Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Period 1OTHER1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state
Treatment Period 2OTHER1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
Treatment Period 3OTHER1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state

Interventions

NameTypeDescription
Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted stateDRUG1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state
Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted stateDRUG1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted stateDRUG1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Alanine transaminase (ALT), alkaline phosphatase and bilirubin ≤ 1.5 x upper limit of normal (ULN; isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated an...

Countries:Australia
Unlock Eligibility Criteria

Competitive Landscape -Hypertension 41 trials

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY4PHASE3Orforglipron
Alnylam Pharmaceuticals, IncALNY2PHASE3Zilebesiran
Mineralys Therapeutics, Inc.MLYS1PHASE3lorundrostat
United Therapeutics CorporationUTHR1PHASE3Ralinepag
Novartis AG Sponsored ADRNVS2PHASE2QCZ484
Vanda Pharmaceuticals Inc.VNDA1PHASE2iloperidone
AstraZeneca PLCAZN2 - Undisclosed
Opus Genetics, Inc.IRD1PHASE1OPGx-BEST1
Orchestra BioMed Holdings, Inc.OBIO3N/AUndisclosed
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
CVRx, Inc.CVRX2N/AMedical Management
Medtronic PlcMDT4N/AUndisclosed
IQVIA Holdings IncIQV1N/AUndisclosed
Verve Medical, IncVERV1N/AActive hypertension medical therapy
Tango Therapeutics, Inc.TNGX1N/ATriple Fixed-Dose Combination, Usual Care Antihypertensive Regimen
Unlock Competitive Intelligence