HypertensionPhase 3NCT00546052

A 52 Week Study to Evaluate the Effects of Losartan With or Without HCTZ on Plasma Glucose, Metabolic Parameters, Blood Pressure in Hypertensive Patients With Metabolic Syndrome (0954A-331)

A Phase 3 study testing losartan potassium (+) hydrochlorothiazide in people with Hypertension and Metabolic Disorder, 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

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Metabolic Disorder
What is being tested?: losartan potassium (+) hydrochlorothiazide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,738 participants
Where: No sites listed yet
Study dates: 1 Sep 2005to 1 Jan 2008
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:
abdominal (central) obesity as defined by the waist circumference in men of > 102 cm and women of > 88 cm or a BMI equal or greater than 30 kg/m2
and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp < 180/110 mm Hg
or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:
bp equal or greater than 140/90 mm Hg but equal or less than 160/100 mm Hg
or a patient whose hypertension is controlled (< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:

Show all 9Show fewer

Fasting plasma glucose equal or greater than 5.6 mmol/L and < 7.0 mmol/L
Triglycerides > 1.7 mmol/L or specific treatment for this lipid abnormality
HDL-c in men < 0.9 mmol/L and in women < 1.1 mmol/L or specific treatment for this lipid abnormality

Who cannot join

A Patient With A Diagnosis Of Type II Diabetes Defined As Fasting Blood Glucose Level Equal Or Greater Than 7.0 Mmol/L Or A 2hpg In A 75-G OGTT Equal Or Greater Than 11.1 Mol/L Or Using Any Anti-Hyperglycemic Agents
Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Or Hypertensive Encephalopathy)
Patient Intolerant To Any Component Of Losartan 50 Mg / Losartan 100 Mg / Losartan 100 Mg + Hctz 12.5 Mg / Losartan 100 Mg + Hctz 25 Mg Or With A Documented History Of Angioedema
Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance On The Basis Of The Case History Or A Recent Laboratory Test (Serum Creatinine > 130 Mmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 2 Times Above The Normal Range, Alt > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L)
Patient With Symptomatic Heart Failure (Classes 3 And 4)
Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
Patient Who Has Undergone Percutaneous Coronary Angioplasty Or Coronary Artery Bypass Within The Last 3 Months
Pregnant Woman Or A Woman Of Childbearing Potential

About this study

Official title: 52 Week Study to Evaluate the Effects of LOSARTAN 50 mg, 100 mg, 100/12.5 mg HCTZ, 100/25 mg HCTZ on Metabolic Parameters, Blood Pressure and Safety in Hypertensive Patients With Metabolic Syndrome

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.

Conditions: Hypertension, Metabolic Disorder
Being tested: losartan potassium (+) hydrochlorothiazide
Medical subject headings: Hypertension, Metabolic Diseases

What participants receive

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

losartan potassium (+) hydrochlorothiazideDrug
Also called Cozaar/Hyzaar
All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.

Study groups in NCT00546052
Study group	Role	What they receive
1	Experimental	Losartan (MK0954) / Losartan + HCTZ (MK0954A) Receives: Drug: losartan potassium (+) hydrochlorothiazide

What is being measured

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

Change in Hemoglobin A1c Between 52 Weeks and Baseline
Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Measured: 52 Weeks - Baseline
Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.
Measured: 52 Weeks - Baseline

Secondary outcomes (3)

Target Blood Pressure
Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks
Measured: 52 Weeks
Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments
Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.
Measured: 52 Weeks - Baseline
Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments
Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.
Measured: 52 Weeks - Baseline

Timeline

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

1 Sep 20051 Jan 2008

First posted18 Oct 2007 (estimated)
Study start1 Sep 2005
Primary completion1 Jan 2008
Study completion1 Jan 2008

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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,738 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00546052
Sponsor's protocol ID: 0954A-331
Other IDs: MK0954A-331, 2007_030
Status last verified: Feb 2022
First submitted: 17 Oct 2007
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Racine N, Hamet P, Sampalis JS, Longo N, Bastien N. A 52-week prospective, cohort study of the effects of losartan with or without hydrochlorothiazide (HCTZ) in hypertensive patients with metabolic syndrome. J Hum Hypertens. 2010 Nov;24(11):739-48. doi: 10.1038/jhh.2010.3. Epub 2010 Feb 11.
PubMed 20147971

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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 52 Week Study to Evaluate the Effects of LOSARTAN 50 mg, 100 mg, 100/12.5 mg HCTZ, 100/25 mg HCTZ on Metabolic Parameters, Blood Pressure and Safety in Hypertensive Patients With Metabolic Syndrome
ClinicalTrials.gov ID: NCT00546052
Acronym / sponsor ID: 0954A-331
Conditions: Hypertension, Metabolic Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,738 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Sep 2005 (actual)
Primary completion: 1 Jan 2008 (actual)
Study completion: 1 Jan 2008 (actual)
First posted: 18 Oct 2007 (estimated)
Results: Posted 23 Jun 2009

Clinical summary

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

To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: losartan potassium (+) hydrochlorothiazideLosartan (MK0954) / Losartan + HCTZ (MK0954A)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:
and untreated hypertension with bp equal or greater than 140/90 mm Hg but bp < 180/110 mm Hg
or a patient receiving one or two antihypertensive agent(s) (diuretics, ace inhibitors, angiotensin ii receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) and whose blood pressure is not controlled:
bp equal or greater than 140/90 mm Hg but equal or less than 160/100 mm Hg
or a patient whose hypertension is controlled (< 140/90 mm hg) with a single anti-hypertensive agent (diuretics, ace inhibitors, and angiotensin II receptor blockers, calcium channel blockers and beta-blockers will need to be discontinued) but who is unsatisfied or experiencing side effects warranting a discontinuation of the previous treatment and at one of the following:

Key exclusion criteria (8 listed)

A Patient With A Diagnosis Of Type II Diabetes Defined As Fasting Blood Glucose Level Equal Or Greater Than 7.0 Mmol/L Or A 2hpg In A 75-G OGTT Equal Or Greater Than 11.1 Mol/L Or Using Any Anti-Hyperglycemic Agents
Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Or Hypertensive Encephalopathy)
Patient Intolerant To Any Component Of Losartan 50 Mg / Losartan 100 Mg / Losartan 100 Mg + Hctz 12.5 Mg / Losartan 100 Mg + Hctz 25 Mg Or With A Documented History Of Angioedema
Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance On The Basis Of The Case History Or A Recent Laboratory Test (Serum Creatinine > 130 Mmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 2 Times Above The Normal Range, Alt > 2 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L)
Patient With Symptomatic Heart Failure (Classes 3 And 4)

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 (+) hydrochlorothiazideAlso: Cozaar/HyzaarAll patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.	Drug	1

Primary outcome

Change in Hemoglobin A1c Between 52 Weeks and Baseline
Time frame: 52 Weeks - Baseline
Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments
Time frame: 52 Weeks - Baseline
Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.

3 secondary outcomes

Target Blood Pressure
Time frame: 52 Weeks
Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments
Time frame: 52 Weeks - Baseline
Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments
Time frame: 52 Weeks - Baseline

Results and safety

Results posted to the registry on 23 Jun 2009, 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 +/- Hydrochlorothiazide	1,738	1,511

Primary outcome: Change in Hemoglobin A1c Between 52 Weeks and Baseline

Time frame: 52 Weeks - Baseline. Median (Standard Deviation). Unit: Percent

Measure	Losartan +/- Hydrochlorothiazide n = 1511
Value	0.04 (0.62)

Losartan +/- Hydrochlorothiazide: Mean Difference (Final Values): 0.02 (95% CI -0.02 to 0.06), p = 0.999, t-test, 1 sided

Population analysed: Per Protocol

Primary outcome: Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments

Time frame: 52 Weeks - Baseline. Mean (Standard Deviation). Unit: mmol/L

Measure	Losartan +/- Hydrochlorothiazide n = 1511
Value	0.02 (0.74)

Losartan +/- Hydrochlorothiazide: Mean Difference (Final Values): 0.04 (95% CI 0.01 to 0.07), p = 0.999, t-test, 1 sided

Population analysed: Per Protocol

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Overall ITT	35 of 1,714 (2%)	198 of 1,714 (11.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20147971Racine N, Hamet P, Sampalis JS, Longo N, Bastien N. A 52-week prospective, cohort study of the effects of losartan with or without hydrochlorothiazide (HCTZ) in hypertensive patients with metabolic syndrome. J Hum Hypertens. 2010 Nov;24(11):739-48. doi: 10.1038/jhh.2010.3. Epub 2010 Feb 11.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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 3 study testing losartan potassium (+) hydrochlorothiazide in people with Hypertension and Metabolic Disorder, 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 9 inclusion and 8 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 16 May 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Jun 2009). 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?

Change in Hemoglobin A1c Between 52 Weeks and Baseline (time frame: 52 Weeks - Baseline). The study lists 2 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 NCT00546052, which also lists 1 linked publication.

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 16 May 2024.