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CompletedNCT00546754EASEUpdated May 16, 2024Results posted

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)

A Phase 3 interventional study of losartan potassium (+) hydrochlorothiazide and Comparator: Valsartan (+) Hydrochlorothiazide in Hypertension, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled May 2007, registered Oct 2007).
Phase
Phase 3
Study type
Interventional
Enrollment
808
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment.

02

Conditions studied

  • Hypertension

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03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 808 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Browse Organon & Co. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • An Adult Patient 18 to 75 Years Of Age
  • Patient with essential hypertension receiving an antihypertensive agent in monotherapy for at least 4 weeks for whom the antihypertensive agent can (and will) be discontinued and whose blood pressure is not controlled:
  • Either systolic or diastolic blood pressure > 140/90 mm Hg up to 180/110 mm Hg (inclusive)
  • Either systolic or diastolic blood pressure > 130/80 mm Hg up to 160/100 mm Hg (inclusive) for diabetic patients

  • Patient is male or a female who is highly unlikely to conceive as she falls into one of the categories listed below:

    • Surgically sterilized female
    • Postmenopausal female > 45 years of age with > 2 years since her last menses
    • Non-sterilized pre-menopausal female who agrees to: (1) use 2 adequate methods of contraception to prevent pregnancy [either 2 barrier methods or a barrier method plus a hormonal method]; or (2) abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication; or (3) only engage in heterosexual activity with surgically sterilized male partner(s) throughout the study starting with Visit 1 and for 14 days after the last dose of study medication
    • Patient judged to be in otherwise good, stable health on the basis of medical history and physical examination

Exclusion criteria

Exclusion Criteria:

  • Known secondary hypertension of any aetiology (e.g., uncorrected renal artery stenosis, malignant hypertension, or hypertensive encephalopathy)
  • Patient Needing An Initiation Of A Lipid Lowering Agent Or A Modification Of His Lipid Therapy At Visit 1 Or During The Study Period (12 Weeks)
  • Patient taking allopurinol
  • Patient Previously Shown To Be Intolerant To Any Component Of Losartan Valsartan, Or HCTZ Or With A Documented History Of Angioedema/Anaphylaxis
  • Patient With Confirmed Clinically Significant Renal Or Hepatic Dysfunction And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Umol/L Or Creatinine Clearance \< 45 Ml/Min, Aspartate transaminase (AST) > 2 Times Above The Normal Range, Alanine transaminase (ALT) > 2 Times Above The Normal Range, Serum Potassium \< 3.5 Or > 5.5 Meq/L
  • Patient with osteoarthritis who has undergone hip or knee replacement within the last 4 months
  • Patient with chronic inflammatory conditions such as rheumatoid arthritis, lupus, inflammatory bowel disease and those that need a chronic inflammatory therapy such as prednisone or other steroid agents
  • Patient with symptomatic heart failure (classes 3 and 4)
  • Patient with a history of stroke within the last 6 months
  • Patient with coronary heart disease: has undergone percutaneous coronary angioplasty, has had coronary artery bypass, has had past myocardial infarction, all that occurred less than 6 months prior to visit 1 or has unstable angina
  • Patient having participated in an investigational drug program in the last 30 days (prior to Visit 1)
  • Unable or unwilling to comply with the protocol, therefore likely to leave the trial before its completion
  • Patient intends to move or to vacation away from home during the course of the study which would interfere with the scheduled visits.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
808 participants (actual)

Study arms

  • Experimental
    1

    Drug Arm

    Drug: losartan potassium (+) hydrochlorothiazide

  • Active comparator
    2

    active comparator

    Drug: Comparator: Valsartan (+) Hydrochlorothiazide

Interventions

  • Druglosartan potassium (+) hydrochlorothiazide

    losartan potassium 50 mg/12.5 Hydrochlorothiazide (HCTZ) titrated as needed to losartan potassium 100 mg/25 mg Hydrochlorothiazide

  • DrugComparator: Valsartan (+) Hydrochlorothiazide

    Valsartan 80 mg/ Hydrochlorothiazide 12.5 mg/day titrated as needed to valsartan 160 mg/25 mg Hydrochlorothiazide

06

What researchers measure

Primary outcomes

  1. Change in Systolic Blood Pressure From Baseline to Week 12

    Time frame: Baseline and Week 12

  2. Change in Diastolic Blood Pressure From Baseline to Week 12

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Change in Systolic Blood Pressure From Baseline to Week 6

    Time frame: Baseline and Week 6

  2. Change in Diastolic Blood Pressure From Baseline to Week 6

    Time frame: Baseline and Week 6

  3. Number of Patients Achieving Target Blood Pressure at Week 6

    Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 6

    Time frame: Week 6

  4. Number of Patients Achieving Target Blood Pressure at Week 12

    Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 12

    Time frame: 12 Weeks

  5. Time to Achieve Target Blood Pressure

    Time to achieve the target blood pressure (\<140/90 mmHg and \<130/80 mmHg for diabetics)

    Time frame: 12 weeks

  6. Change in Uric Acid From Baseline to Week 6

    Time frame: Baseline and Week 6

  7. Change in Uric Acid From Baseline to Week 12

    Time frame: Baseline and Week 12

  8. Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6

    Time frame: Baseline and Week 6

  9. Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12

    Time frame: Baseline and Week 12

  10. Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6

    Time frame: Baseline and Week 6

  11. Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12

    Time frame: Baseline and Week 12

07

Results

Posted Apr 13, 2010

Participant flow

First patient in: MAY-04-2007 Last patient out: APRIL-16-2009 Total number of sites: 163 sites in Canada

Participant flow — Overall Study
MilestoneLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Started425383
Treated416373
Week 6396347
Week 12375334
Completed375334
Not completed5049
Withdrew: Serious adverse event11
Withdrew: Adverse event1116
Withdrew: Lack of efficacy11
Withdrew: Lost to follow-up915
Withdrew: Protocol violation30
Withdrew: Withdrawal by subject67
Withdrew: Dyspnea10
Withdrew: Per data query, less than 4 wks coversyl10
Withdrew: Hip replacement10
Withdrew: Suicide10
Withdrew: Missing cooperation10
Withdrew: Elevated creatinine and potassium levels01
Withdrew: Patient's decision01
Withdrew: Missing147

Outcome measures

SecondaryChange in Systolic Blood Pressure From Baseline to Week 6
Time frame:
Baseline and Week 6
Reported as:
Mean · mm Hg
Change in Systolic Blood Pressure From Baseline to Week 6
mm HgLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Systolic Blood Pressure From Baseline to Week 6-16.7 ± 14.70-18.2 ± 13.84
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.153
SecondaryChange in Diastolic Blood Pressure From Baseline to Week 6
Time frame:
Baseline and Week 6
Reported as:
Mean · mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 6
mm HgLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Diastolic Blood Pressure From Baseline to Week 6-8.4 ± 9.35-9.1 ± 9.16
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.343
SecondaryNumber of Patients Achieving Target Blood Pressure at Week 6

Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 6

Time frame:
Week 6
Reported as:
Number · Patients
Number of Patients Achieving Target Blood Pressure at Week 6
PatientsLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Achieved Target Blood Pressure253241
Did Not Achieve Target Blood Pressure140104
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · Fisher Exact · p = 0.118
PrimaryChange in Systolic Blood Pressure From Baseline to Week 12
Time frame:
Baseline and Week 12
Reported as:
Mean · mm Hg
Change in Systolic Blood Pressure From Baseline to Week 12
mm HgLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Systolic Blood Pressure From Baseline to Week 12-19.9 ± 13.79-20.8 ± 13.61
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.395
SecondaryNumber of Patients Achieving Target Blood Pressure at Week 12

Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 12

Time frame:
12 Weeks
Reported as:
Number · Patients
Number of Patients Achieving Target Blood Pressure at Week 12
PatientsLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Achieved Target Blood Pressure278253
Did Not Achieve Target Blood Pressure9479
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · Fisher Exact · p = 0.662
SecondaryTime to Achieve Target Blood Pressure

Time to achieve the target blood pressure (\<140/90 mmHg and \<130/80 mmHg for diabetics)

Time frame:
12 weeks
Reported as:
Mean · Days
Time to Achieve Target Blood Pressure
DaysLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Time to Achieve Target Blood Pressure62.3 ± 1.4457.3 ± 1.24
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · Log Rank · p = 0.020
SecondaryChange in Uric Acid From Baseline to Week 6
Time frame:
Baseline and Week 6
Reported as:
Mean · umol/L
Change in Uric Acid From Baseline to Week 6
umol/LLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Uric Acid From Baseline to Week 60.3 ± 53.1221.7 ± 55.09
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = <0.001
PrimaryChange in Diastolic Blood Pressure From Baseline to Week 12
Time frame:
Baseline and Week 12
Reported as:
Mean · mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 12
mm HgLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Diastolic Blood Pressure From Baseline to Week 12-10.6 ± 9.28-10.5 ± 9.58
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.935
SecondaryChange in Uric Acid From Baseline to Week 12
Time frame:
Baseline and Week 12
Reported as:
Mean · umol/L
Change in Uric Acid From Baseline to Week 12
umol/LLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Uric Acid From Baseline to Week 12-0.4 ± 57.0229.9 ± 64.79
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = <0.001
SecondaryChange in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
Time frame:
Baseline and Week 6
Reported as:
Mean · mg/L
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
mg/LLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 60.8 ± 26.210.6 ± 6.60
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.899
SecondaryChange in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
Time frame:
Baseline and Week 12
Reported as:
Mean · umol/L
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
umol/LLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12-0.3 ± 8.050.5 ± 7.20
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.218
SecondaryChange in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
Time frame:
Baseline and Week 6
Reported as:
Mean · IU/L
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
IU/LLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6-1.8 ± 21.20-0.1 ± 24.71
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.386
SecondaryChange in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
Time frame:
Baseline and Week 12
Reported as:
Mean · IU/L
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
IU/LLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12-0.7 ± 21.44-0.0 ± 24.45
Statistical analysis
  • Losartan 50 mg/HCTZ 12.5 mg vs Valsartan 80 mg/HCTZ 12.5 mg · ANOVA · p = 0.725

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Losartan 50 mg/HCTZ 12.5 mg—11/425 (2.6%)56/425 (13.2%)
Valsartan 80 mg/HCTZ 12.5 mg—5/383 (1.3%)57/383 (14.9%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
SyncopeNervous system disorders1/4252/383
Chest painGeneral disorders0/4251/383
Cholecystitis acuteHepatobiliary disorders0/4251/383
Renal failureRenal and urinary disorders0/4251/383
Pulmonary oedemaRespiratory, thoracic and mediastinal disorders0/4251/383
Acute myocardial infarctionCardiac disorders1/4250/383
Barrett's oesophagusGastrointestinal disorders1/4250/383
Gastrointestinal haemorrhageGastrointestinal disorders1/4250/383
Pneumonia klebsiellaInfections and infestations1/4250/383
Lung neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/4250/383
Most frequent other events
Showing 10 of 69
Most frequent other events
EventLosartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mg
C-Reactive protein increasedInvestigations7/4253/383
DizzinessNervous system disorders3/4254/383
HeadacheNervous system disorders4/4254/383
Abdominal pain upperGastrointestinal disorders3/4251/383
DiarrhoeaGastrointestinal disorders3/4250/383
Blood potassium increasedInvestigations3/4251/383
VomitingGastrointestinal disorders0/4252/383
HypersensitivityImmune system disorders0/4252/383
Wrong technique in drug usage processInjury, poisoning and procedural complications0/4252/383
MyalgiaMusculoskeletal and connective tissue disorders0/4252/383

Baseline characteristics

Age, Continuous
Age, Continuous(years)Losartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mgTotal
Mean58.7 ± 11.1158.3 ± 10.2658.5 ± 10.71
Sex: Female, Male
Sex: Female, Male(Participants)Losartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mgTotal
Female197180377
Male219193412
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Losartan 50 mg/HCTZ 12.5 mgValsartan 80 mg/HCTZ 12.5 mgTotal
Caucasian364326690
Black81321
Hispanic202
Asian342963
Native448
East Indian101
From Middle East101
Unknown213
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00546754
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 19, 2007
Start date
May 1, 2007
Primary completion
Apr 1, 2009
Completion
May 1, 2009
Results posted
Apr 13, 2010
Last update
May 16, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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