NCT01102478

Brief Summary

The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2005

Shorter than P25 for not_applicable 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

February 1, 2005

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

28 days

First QC Date

April 9, 2010

Last Update Submit

January 19, 2018

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence determined by statistical comparison Cmax

    25 days

Interventions

losartan potassium / hydrochlorothiazideDRUG

100 mg / 25 mg tablet

Also known as: Hyzaar

Eligibility Criteria

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

You may qualify if:

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

You may not qualify if:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEDRA Clinical Research, LLC

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Daniel V Freeland, D.O.

    CEDRA Clinical Research, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 13, 2010

Study Start

February 1, 2005

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

US(1)