NCT00953680

Brief Summary

This study will evaluate the bioequivalence of the losartan/hydrochlorothiazide (HCTZ) combination tablet and coadministration of losartan and hydrochlorothiazide.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 16, 2010

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

1 month

First QC Date

August 4, 2009

Results QC Date

May 13, 2010

Last Update Submit

February 7, 2022

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

  • Area Under the Curve (AUC(0 to Infinity)) of Losartan

    0 to 36 Hours Post Dose

  • Peak Plasma Concentration (Cmax) for Losartan

    Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.

    36 Hours Post Dose

  • Area Under the Curve (AUC(0 to Infinity)) of HCTZ

    Plasma Area Under the Curve, a measure of drug exposure following dosing

    0 to 30 Hours Post Dose

  • Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ

    Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

    30 Hours Post Dose

Study Arms (2)

losartan /HCTZ combination tablet

ACTIVE COMPARATOR

single dose losartan 100 mg/HCTZ 12.5 mg combination tablet

Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)

losartan tablet + HCTZ capsule

ACTIVE COMPARATOR

Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule

Drug: losartan potassiumDrug: hydrochlorothiazide (HCTZ)

Interventions

losartan potassium (+) hydrochlorothiazide (HCTZ)DRUG

Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.

losartan /HCTZ combination tablet
losartan potassiumDRUG

Single dose losartan 100 mg tablet in one of two treatment periods.

Also known as: COZAAR™
losartan tablet + HCTZ capsule
hydrochlorothiazide (HCTZ)DRUG

Single dose HCTZ 12.5 mg capsule in one of two treatment periods.

Also known as: MICROZIDE™
losartan tablet + HCTZ capsule

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is a healthy male or female between the ages of 18 and 45 years of age
  • Subject does not smoke

You may not qualify if:

  • Subject has a history of any illness that might pose additional risk to participation or confound the results of the study
  • Subject has a history of hepatitis B or C or significant drug allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combinationLosartanHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

PK analyses included complete data from 75 subjects. 3 losartan/E-3174 concentrations from 3 different subjects were excluded from analyses due to gross deviations; 75 minutes-Treatment B, 75 minutes-Treatment A, \& 15 minutes-Treatment A.

Results Point of Contact

Title
Executive Vice President, Clinical and Quantitative Sciences
Organization
Merck Sharp & Dohme Corp
1-800-672-6372

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

August 4, 2009

First Posted

August 6, 2009

Study Start

April 1, 2004

Primary Completion

May 1, 2004

Study Completion

July 1, 2004

Last Updated

February 9, 2022

Results First Posted

July 16, 2010

Record last verified: 2022-02