Trial · NCT00546052

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)

NCT00546052, Phase 3, Completed, Organon and Co; results first posted 2009-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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). Trials, record NCT00546052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00546052

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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)
NCT number: NCT00546052
Status: Completed
Phases: Phase 3
Enrollment: 1,738 participants, actual
Lead sponsor: Organon and Co
Conditions: Hypertension, Metabolic Disorder
Interventions: losartan potassium (+) hydrochlorothiazide
First posted: 2007-10-18
Last updated: 2024-05-16
Results first posted: 2009-06-23

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Hemoglobin A1c Between 52 Weeks and Baseline	52 Weeks - Baseline	Absolute Change in Hemoglobin A1c between 52 week measurement and baseline value.
Primary	Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments	52 Weeks - Baseline	Absolute Change in Fasting Blood Glucose Measurements between Baseline and 52 week assessments.
Secondary	Target Blood Pressure	52 Weeks	Target Blood Pressure defined as Systolic Blood Pressure/Diastolic Blood Pressure ≤ 140/90 mm Hg at 52 weeks
Secondary	Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Absolute change in Systolic Blood Pressure between baseline and 52 week assessments.
Secondary	Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Absolute change in Diastolic Blood Pressure between baseline and 52 week assessments.
Other	Change in Waist Circumference Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Absolute change in Waist Circumference between baseline and 52 week assessments
Other	Change in Body Mass Index Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Absolute change in Body Mass Index Baseline and 52 week assessments
Other	Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Percent Change in LDL-C Between Baseline and 52 week assessments: 100% x \[(LDL-C 52 Weeks - LDL-C Baseline) / (LDL-C Baseline)\].
Other	Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Percent Change in HDL-C Between Baseline and 52 week assessments: 100% x \[(HDL-C 52 Weeks - HDL-C 52 Baseline) / (HDL-C Baseline)\].
Other	Percent Change in Triglycerides Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Percent Change in Triglycerides Between Baseline and 52 week assessments: 100% x \[(Triglycerides 52 Weeks - Triglycerides Baseline) / (Triglycerides Baseline)\].

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Hemoglobin A1c Between 52 Weeks and Baseline	52 Weeks - Baseline	Per Protocol	Percent	MEDIAN
PRIMARY	Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments	52 Weeks - Baseline	Per Protocol	mmol/L	MEAN
SECONDARY	Target Blood Pressure	52 Weeks	ITT and Per Protocol	Participants	NUMBER
SECONDARY	Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	mm Hg	MEAN
SECONDARY	Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	mm Hg	MEAN
OTHER_PRE_SPECIFIED	Change in Waist Circumference Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	cm	MEAN
OTHER_PRE_SPECIFIED	Change in Body Mass Index Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	Kg/m2	MEAN
OTHER_PRE_SPECIFIED	Percent Change in Low Density Lipoprotein-C Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	Percent Change	MEAN
OTHER_PRE_SPECIFIED	Percent Change in High Density Lipoprotein-C Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	Percent Change	MEAN
OTHER_PRE_SPECIFIED	Percent Change in Triglycerides Between Baseline and 52 Week Assessments	52 Weeks - Baseline	Per Protocol	Percent Change	MEDIAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Hemoglobin A1c Between 52 Weeks and Baseline	Losartan +/- Hydrochlorothiazide		0.04	Standard Deviation 0.62	Percent
Change in Fasting Blood Glucose Between Baseline and 52 Weeks Assessments	Losartan +/- Hydrochlorothiazide		0.02	Standard Deviation 0.74	mmol/L
Target Blood Pressure	Overall Total	Achieved Target Blood Pressure	1200		Participants
Target Blood Pressure	Overall Intend to Treat	Achieved Target Blood Pressure	1200		Participants
Target Blood Pressure	Overall Per Protocol	Achieved Target Blood Pressure	1200		Participants
Target Blood Pressure	Overall Total	Did NOT achieve target Blood Pressure	538		Participants
Target Blood Pressure	Overall Intend to Treat	Did NOT achieve target Blood Pressure	514		Participants
Target Blood Pressure	Overall Per Protocol	Did NOT achieve target Blood Pressure	311		Participants
Change in Systolic Blood Pressure Between Baseline and 52 Week Assessments	Losartan +/- Hydrochlorothiazide		-16.95	Standard Deviation 13.34	mm Hg
Change in Diastolic Blood Pressure Between Baseline and 52 Week Assessments	Losartan +/- Hydrochlorothiazide		-9.84	Standard Deviation 8.93	mm Hg

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Losartan +/- Hydrochlorothiazide	1,738
Overall Study	Week 4	Losartan +/- Hydrochlorothiazide	1,714
Overall Study	Week 8	Losartan +/- Hydrochlorothiazide	1,680
Overall Study	Week 12	Losartan +/- Hydrochlorothiazide	1,650
Overall Study	Week 32	Losartan +/- Hydrochlorothiazide	1,583
Overall Study	Week 52	Losartan +/- Hydrochlorothiazide	1,511
Overall Study	COMPLETED	Losartan +/- Hydrochlorothiazide	1,511
Overall Study	NOT COMPLETED	Losartan +/- Hydrochlorothiazide	227

Source ClinicalTrials.gov

Adverse events37

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Type 2 diabetes mellitus	Metabolism and nutrition disorders	Overall ITT	54	1,714
other	Dizziness	Nervous system disorders	Overall ITT	35	1,714
other	Bronchitis	Respiratory, thoracic and mediastinal disorders	Overall ITT	29	1,714
other	Osteoarthritis	Musculoskeletal and connective tissue disorders	Overall ITT	23	1,714
other	Headache	Nervous system disorders	Overall ITT	21	1,714
other	Sinusitis	Infections and infestations	Overall ITT	19	1,714
other	Blood Glucose Increased (per investigator's clinical judgment)	Investigations	Overall ITT	17	1,714
serious	Acute coronary syndrome	Cardiac disorders	Overall ITT	1	1,714
serious	Acute depression	Psychiatric disorders	Overall ITT	1	1,714
serious	Acute renal insufficiency	Renal and urinary disorders	Overall ITT	1	1,714

1 to 10 of 37Source ClinicalTrials.gov

See all 37 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Overall ITT
Total, other adverse events	Overall ITT	198	1,714
Total, serious adverse events	Overall ITT	35	1,714

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20147971	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00546052

GET https://conductscience.org/api/trials/v1/NCT00546052/events?page=2

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