Trial · NCT00546754

BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)

NCT00546754, Phase 3, Completed, Organon and Co; results first posted 2010-04-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333). Trials, record NCT00546754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00546754

On this page

Trial

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

Title: BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)
NCT number: NCT00546754
Status: Completed
Phases: Phase 3
Enrollment: 808 participants, actual
Lead sponsor: Organon and Co
Conditions: Hypertension
Interventions: losartan potassium (+) hydrochlorothiazide, Comparator: Valsartan (+) Hydrochlorothiazide
First posted: 2007-10-19
Last updated: 2024-05-16
Results first posted: 2010-04-13

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 Systolic Blood Pressure From Baseline to Week 12	Baseline and Week 12
Primary	Change in Diastolic Blood Pressure From Baseline to Week 12	Baseline and Week 12
Secondary	Change in Systolic Blood Pressure From Baseline to Week 6	Baseline and Week 6
Secondary	Change in Diastolic Blood Pressure From Baseline to Week 6	Baseline and Week 6
Secondary	Number of Patients Achieving Target Blood Pressure at Week 6	Week 6	Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 6
Secondary	Number of Patients Achieving Target Blood Pressure at Week 12	12 Weeks	Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 12
Secondary	Time to Achieve Target Blood Pressure	12 weeks	Time to achieve the target blood pressure (\<140/90 mmHg and \<130/80 mmHg for diabetics)
Secondary	Change in Uric Acid From Baseline to Week 6	Baseline and Week 6
Secondary	Change in Uric Acid From Baseline to Week 12	Baseline and Week 12
Secondary	Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6	Baseline and Week 6

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
SECONDARY	Change in Systolic Blood Pressure From Baseline to Week 6	Baseline and Week 6	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	mm Hg	MEAN
SECONDARY	Change in Diastolic Blood Pressure From Baseline to Week 6	Baseline and Week 6	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	mm Hg	MEAN
SECONDARY	Number of Patients Achieving Target Blood Pressure at Week 6	Week 6	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	Patients	NUMBER
PRIMARY	Change in Systolic Blood Pressure From Baseline to Week 12	Baseline and Week 12	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	mm Hg	MEAN
SECONDARY	Number of Patients Achieving Target Blood Pressure at Week 12	12 Weeks	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	Patients	NUMBER
SECONDARY	Time to Achieve Target Blood Pressure	12 weeks	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	Days	MEAN
SECONDARY	Change in Uric Acid From Baseline to Week 6	Baseline and Week 6	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	umol/L	MEAN
PRIMARY	Change in Diastolic Blood Pressure From Baseline to Week 12	Baseline and Week 12	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	mm Hg	MEAN
SECONDARY	Change in Uric Acid From Baseline to Week 12	Baseline and Week 12	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	umol/L	MEAN
SECONDARY	Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6	Baseline and Week 6	416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively	mg/L	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group30

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

Outcome	Group	Category	Value	Spread	Units
Change in Systolic Blood Pressure From Baseline to Week 6	Losartan 50 mg/HCTZ 12.5 mg		-16.7	Standard Deviation 14.70	mm Hg
Change in Systolic Blood Pressure From Baseline to Week 6	Valsartan 80 mg/HCTZ 12.5 mg		-18.2	Standard Deviation 13.84	mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 6	Losartan 50 mg/HCTZ 12.5 mg		-8.4	Standard Deviation 9.35	mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 6	Valsartan 80 mg/HCTZ 12.5 mg		-9.1	Standard Deviation 9.16	mm Hg
Number of Patients Achieving Target Blood Pressure at Week 6	Losartan 50 mg/HCTZ 12.5 mg	Achieved Target Blood Pressure	253		Patients
Number of Patients Achieving Target Blood Pressure at Week 6	Valsartan 80 mg/HCTZ 12.5 mg	Achieved Target Blood Pressure	241		Patients
Number of Patients Achieving Target Blood Pressure at Week 6	Losartan 50 mg/HCTZ 12.5 mg	Did Not Achieve Target Blood Pressure	140		Patients
Number of Patients Achieving Target Blood Pressure at Week 6	Valsartan 80 mg/HCTZ 12.5 mg	Did Not Achieve Target Blood Pressure	104		Patients
Change in Systolic Blood Pressure From Baseline to Week 12	Losartan 50 mg/HCTZ 12.5 mg		-19.9	Standard Deviation 13.79	mm Hg
Change in Systolic Blood Pressure From Baseline to Week 12	Valsartan 80 mg/HCTZ 12.5 mg		-20.8	Standard Deviation 13.61	mm Hg

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Losartan 50 mg/HCTZ 12.5 mg	425
Overall Study	STARTED	Valsartan 80 mg/HCTZ 12.5 mg	383
Overall Study	Treated	Losartan 50 mg/HCTZ 12.5 mg	416
Overall Study	Treated	Valsartan 80 mg/HCTZ 12.5 mg	373
Overall Study	Week 6	Losartan 50 mg/HCTZ 12.5 mg	396
Overall Study	Week 6	Valsartan 80 mg/HCTZ 12.5 mg	347
Overall Study	Week 12	Losartan 50 mg/HCTZ 12.5 mg	375
Overall Study	Week 12	Valsartan 80 mg/HCTZ 12.5 mg	334
Overall Study	COMPLETED	Losartan 50 mg/HCTZ 12.5 mg	375
Overall Study	COMPLETED	Valsartan 80 mg/HCTZ 12.5 mg	334

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events168

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	Events
other	Vertigo	Ear and labyrinth disorders	Losartan 50 mg/HCTZ 12.5 mg	0	425	0
other	Vertigo	Ear and labyrinth disorders	Valsartan 80 mg/HCTZ 12.5 mg	1	383	1
other	Visual disturbance	Eye disorders	Losartan 50 mg/HCTZ 12.5 mg	1	425	1
other	Visual disturbance	Eye disorders	Valsartan 80 mg/HCTZ 12.5 mg	0	383	0
other	Abdominal discomfort	Gastrointestinal disorders	Losartan 50 mg/HCTZ 12.5 mg	0	425	0
other	Abdominal discomfort	Gastrointestinal disorders	Valsartan 80 mg/HCTZ 12.5 mg	1	383	1
other	Abdominal pain upper	Gastrointestinal disorders	Losartan 50 mg/HCTZ 12.5 mg	3	425	3
other	Abdominal pain upper	Gastrointestinal disorders	Valsartan 80 mg/HCTZ 12.5 mg	1	383	1
other	Diarrhoea	Gastrointestinal disorders	Losartan 50 mg/HCTZ 12.5 mg	3	425	3
other	Diarrhoea	Gastrointestinal disorders	Valsartan 80 mg/HCTZ 12.5 mg	0	383	0

1 to 10 of 168Source ClinicalTrials.gov

See all 168 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Losartan 50 mg/HCTZ 12.5 mg
Total, all-cause mortality	Valsartan 80 mg/HCTZ 12.5 mg
Total, other adverse events	Losartan 50 mg/HCTZ 12.5 mg	56	425
Total, other adverse events	Valsartan 80 mg/HCTZ 12.5 mg	57	383
Total, serious adverse events	Losartan 50 mg/HCTZ 12.5 mg	11	425
Total, serious adverse events	Valsartan 80 mg/HCTZ 12.5 mg	5	383

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

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

Comparison
Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg: serious adverse events

Source Trial comparisons

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/NCT00546754

GET https://conductscience.org/api/trials/v1/NCT00546754/results?page=2

API reference For AI assistants