HypertensionPhase 1NCT00953680

Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

A Phase 1 study testing losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium and hydrochlorothiazide (HCTZ) in people with Hypertension, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium and hydrochlorothiazide (HCTZ)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: No sites listed yet
Study dates: Apr 2004to Jul 2004
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults

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

Conditions: Hypertension
Being tested: losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium, hydrochlorothiazide (HCTZ)
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

losartan potassium (+) hydrochlorothiazide (HCTZ)Drug
Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.
losartan potassiumDrug
Also called COZAAR™
Single dose losartan 100 mg tablet in one of two treatment periods.
hydrochlorothiazide (HCTZ)Drug
Also called MICROZIDE™
Single dose HCTZ 12.5 mg capsule in one of two treatment periods.

Study groups in NCT00953680
Study group	Role	What they receive
losartan /HCTZ combination tablet	Active comparator	single dose losartan 100 mg/HCTZ 12.5 mg combination tablet Receives: Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)
losartan tablet + HCTZ capsule	Active comparator	Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule Receives: Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUC(0 to Infinity)) of Losartan
Measured: 0 to 36 Hours Post Dose
Peak Plasma Concentration (Cmax) for Losartan
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.
Measured: 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
Measured: 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
Measured: 30 Hours Post Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2004Jul 2004

First posted6 Aug 2009 (estimated)
Study startApr 2004
Primary completionMay 2004
Study completionJul 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00953680
Sponsor's protocol ID: 0954A-306
Other IDs: 2009_628
Status last verified: Feb 2022
First submitted: 4 Aug 2009
Last updated: 9 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence After Administration of a Losartan 100-mg/Hydrochlorothiazide 12.5-mg Combination Tablet and the Coadministration of a Currently Marketed COZAAR™ 100-mg Tablet and MICROZIDE™ 12.5 mg Capsule in Healthy Adults
ClinicalTrials.gov ID: NCT00953680
Acronym / sponsor ID: 0954A-306
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Apr 2004
Primary completion: May 2004 (actual)
Study completion: Jul 2004 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 16 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
losartan /HCTZ combination tablet	Active comparator	Drug: losartan potassium (+) hydrochlorothiazide (HCTZ)single dose losartan 100 mg/HCTZ 12.5 mg combination tablet
losartan tablet + HCTZ capsule	Active comparator	Drug: losartan potassium, Drug: hydrochlorothiazide (HCTZ)Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
losartan potassium (+) hydrochlorothiazide (HCTZ)Single dose losartan 100 mg/HCTZ 12.5 mg combination tablet in one of two treatment periods.	Drug	losartan /HCTZ combination tablet
losartan potassiumAlso: COZAAR™Single dose losartan 100 mg tablet in one of two treatment periods.	Drug	losartan tablet + HCTZ capsule
hydrochlorothiazide (HCTZ)Also: MICROZIDE™Single dose HCTZ 12.5 mg capsule in one of two treatment periods.	Drug	losartan tablet + HCTZ capsule

Primary outcome

Area Under the Curve (AUC(0 to Infinity)) of Losartan
Time frame: 0 to 36 Hours Post Dose
Peak Plasma Concentration (Cmax) for Losartan
Time frame: 36 Hours Post Dose
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing.
Area Under the Curve (AUC(0 to Infinity)) of HCTZ
Time frame: 0 to 30 Hours Post Dose
Plasma Area Under the Curve, a measure of drug exposure following dosing
Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ
Time frame: 30 Hours Post Dose
Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing

Results and safety

Results posted to the registry on 16 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule	38	38
Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet	39	38

Primary outcome: Area Under the Curve (AUC(0 to Infinity)) of Losartan

Time frame: 0 to 36 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng*hr/mL

Measure	Losartan-HCTZ Combination Tablet n = 75	Losartan Tablet + HCTZ Capsule n = 75
Value	1018.1 (382.5)	1024.9 (354.6)

Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule: Least-Squares Mean Ratio: 0.993 (90% CI 0.950 to 1.039)

Population analysed: Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses.

Primary outcome: Peak Plasma Concentration (Cmax) for Losartan

Time frame: 36 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng/mL

Measure	Losartan-HCTZ Combination Tablet n = 75	Losartan Tablet + HCTZ Capsule n = 75
Value	532.7 (334.9)	637.9 (425.3)

Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule: Least-Squares Mean Ratio: 0.835 (90% CI 0.749 to 0.931)

Primary outcome: Area Under the Curve (AUC(0 to Infinity)) of HCTZ

Time frame: 0 to 30 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng*hr/mL

Measure	Losartan-HCTZ Combination Tablet n = 20	Losartan Tablet + HCTZ Capsule n = 20
Value	462.08 (144.72)	499.90 (133.46)

Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule: Least-Squares Mean Ratio: 0.924 (90% CI 0.825 to 1.035)

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

Time frame: 30 Hours Post Dose. Least squares mean (Standard Deviation). Unit: ng/mL

Measure	Losartan-HCTZ Combination Tablet n = 20	Losartan Tablet + HCTZ Capsule n = 20
Value	76.15 (39.55)	81.76 (31.05)

Losartan-HCTZ Combination Tablet vs Losartan Tablet + HCTZ Capsule: Least-Squares Mean Ratio: 0.931 (90% CI 0.836 to 1.037)

Population analysed: Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule	0 of 38 (0%)	12 of 76 (15.8%)	Not reported
Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet	0 of 39 (0%)	10 of 77 (13%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium and hydrochlorothiazide (HCTZ) in people with Hypertension, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUC(0 to Infinity)) of Losartan (time frame: 0 to 36 Hours Post Dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00953680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.