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CompletedNCT00739674Updated May 16, 2024Results posted

SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)

A Phase 3 interventional study of losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) and Low Salt Diet in Hypertension, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.

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

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2008, registered Aug 2008).
Phase
Phase 3
Study type
Interventional
Enrollment
992
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the effectiveness of diet management with a losartan based titration regimen versus losartan based titration regimen alone on blood pressure reduction in hypertensive patients.

02

Conditions studied

  • Hypertension

Browse trials for

03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 992 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; \< 221; 140/90 mm Hg But \< 180/110 mm Hg)
  • Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but \< 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
  • Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;\< 221; 130/80 mm Hg But \< 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;\< 221; 140/90 mm Hg But \< 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;\< 221; 130/80 mm Hg But > 161;\< 221; 150/90 mm Hg
  • The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion criteria

Exclusion Criteria:

  • Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
  • Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
  • Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance \< 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium \< 3.5 Or > 5.5 Meq/L
  • Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
05

Study design

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

Study arms

  • Active comparator
    Losartan-Based Regimen Alone (L Group)

    Losartan-based regimen, with sequential titration including HCTZ and CCB as needed to achieve target blood pressure.

    Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])

  • Experimental
    Diet Management and Losartan-Based Regimen (DML Group)

    Losartan with sequential titration including HCTZ and CCB as needed to achieve target blood pressure combined with low-salt intake diet.

    Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) · Behavioral: Low Salt Diet

Interventions

  • Druglosartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])

    Losartan 50 mg or 100 mg once daily for 40 weeks with sequential titration including HCTZ 12.5 mg or 25 mg and CCB only as needed to achieve target blood pressure, as follows: Patients with mild-moderate hypertension, uncontrolled hypertension on monotherapy, or diabetes: * Losartan 50 mg * Losartan 100 mg * Losartan 100 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 25 mg * Losartan 100 mg/HCTZ 25 mg + CCB Patients with severe hypertension: * Losartan 50 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 12.5 mg * Losartan 100 mg/HCTZ 25 mg * Losartan 100 mg/HCTZ 25 mg + CCB * Losartan 100 mg/HCTZ 25 mg + increasing CCB

  • BehavioralLow Salt Diet

    Low-salt intake diet (Dietary Approaches to Stop Hypertension \[DASH\]) including: * Healthy diet * Reduction in sodium intake to less than 2300 mmol/day * Low alcohol consumption (less than 2 standard drinks/day)

06

What researchers measure

Primary outcomes

  1. Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline

    Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment

    Time frame: 14 Weeks

  2. Change in Systolic Blood Pressure From Baseline to Week 14

    Time frame: 14 Weeks

  3. Change in Diastolic Blood Pressure From Baseline to Week 14

    Time frame: 14 Weeks

Secondary outcomes

  1. Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline

    Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment

    Time frame: 6 Weeks

  2. Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline

    Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment

    Time frame: 10 Weeks

  3. Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline

    Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment

    Time frame: 40 Weeks

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

    Time frame: 6 Weeks

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

    Time frame: 6 Weeks

  6. Change in Systolic Blood Pressure From Baseline to Week 10

    Time frame: 10 Weeks

  7. Change in Diastolic Blood Pressure From Baseline to Week 10

    Time frame: 10 Weeks

  8. Time to Achieve the Target Blood Pressure From Baseline

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

    Time frame: 14 Weeks

07

Results

Posted Aug 11, 2010

Participant flow

First patient in: FEB-05-2008 Last patient out: JAN-15-2010 Total number of sites: 109 sites in Canada

Participant flow — Overall Study
MilestoneLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Started535457
Screening failures1917
Site 212 removal1913
No follow-up data3318
Dietician consultation >30 days19
Intent-to-treat (itt) population463400
Completed354335
Not completed181122
Withdrew: Screening failures1917
Withdrew: Site 212 removal1913
Withdrew: No follow-up data3318
Withdrew: Dietician consultation >30 days19
Withdrew: Adverse event2213
Withdrew: Death10
Withdrew: Lack of efficacy10
Withdrew: Lost to follow-up5230
Withdrew: Protocol violation55
Withdrew: Withdrawal by subject99
Withdrew: Reason missing20
Withdrew: Clinic closed64
Withdrew: Patient moved32
Withdrew: Non compliant40
Withdrew: Unable to attend visit31
Withdrew: Home monitoring off meds10
Withdrew: Erectile dysfunction01

Outcome measures

PrimaryNumber of Patients Achieving Target Blood Pressure at Week 14 From Baseline

Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 14 weeks of treatment

Time frame:
14 Weeks
Reported as:
Number · Participants
Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline
ParticipantsLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Achieve Target Blood Pressure276270
Did not Achieve Target Blood Pressure11687
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Fisher Exact · p = 0.118
SecondaryNumber of Patients Achieving Target Blood Pressure at Week 6 From Baseline

Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 6 weeks of treatment

Time frame:
6 Weeks
Reported as:
Number · Participants
Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline
ParticipantsLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Achieve Target Blood Pressure239231
Did not Achieve Target Blood Pressure192152
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Fisher Exact · p = 0.092
SecondaryNumber of Patients Achieving Target Blood Pressure at Week 10 From Baseline

Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 10 weeks of treatment

Time frame:
10 Weeks
Reported as:
Number · Participants
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline
ParticipantsLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Achieve Target Blood Pressure257254
Did not Achieve Target Blood Pressure142116
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Fisher Exact · p = 0.122
SecondaryNumber of Patients Achieving Target Blood Pressure at Week 40 From Baseline

Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) from baseline after 40 weeks of treatment

Time frame:
40 Weeks
Reported as:
Number · Participants
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline
ParticipantsLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Achieve Target Blood Pressure264240
Did not Achieve Target Blood Pressure8791
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Fisher Exact · p = 0.434
PrimaryChange in Systolic Blood Pressure From Baseline to Week 14
Time frame:
14 Weeks
Reported as:
Mean · mm Hg
Change in Systolic Blood Pressure From Baseline to Week 14
mm HgLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Change in Systolic Blood Pressure From Baseline to Week 14-21.01 ± 14.11-22.74 ± 15.81
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Regression, Linear · p = 0.507Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
PrimaryChange in Diastolic Blood Pressure From Baseline to Week 14
Time frame:
14 Weeks
Reported as:
Mean · mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 14
mm HgLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Change in Diastolic Blood Pressure From Baseline to Week 14-10.19 ± 9.33-12.05 ± 9.50
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Regression, Linear · p = 0.058Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
SecondaryChange in Systolic Blood Pressure From Baseline to Week 6
Time frame:
6 Weeks
Reported as:
Mean · mm Hg
Change in Systolic Blood Pressure From Baseline to Week 6
mm HgLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Change in Systolic Blood Pressure From Baseline to Week 6-16.81 ± 14.92-18.85 ± 16.18
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Regression, Linear · p = 0.158Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
SecondaryChange in Diastolic Blood Pressure From Baseline to Week 6
Time frame:
6 Weeks
Reported as:
Mean · mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 6
mm HgLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Change in Diastolic Blood Pressure From Baseline to Week 6-8.34 ± 9.29-9.76 ± 9.82
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Regression, Linear · p = 0.064Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
SecondaryChange in Systolic Blood Pressure From Baseline to Week 10
Time frame:
10 Weeks
Reported as:
Mean · mm Hg
Change in Systolic Blood Pressure From Baseline to Week 10
mm HgLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Change in Systolic Blood Pressure From Baseline to Week 10-19.11 ± 14.87-20.95 ± 16.24
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Regression, Linear · p = 0.262Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
SecondaryChange in Diastolic Blood Pressure From Baseline to Week 10
Time frame:
10 Weeks
Reported as:
Mean · mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 10
mm HgLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Change in Diastolic Blood Pressure From Baseline to Week 10-9.48 ± 8.80-11.42 ± 9.45
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Regression, Linear · p = 0.026Adjusted for study medication, age, gender, race, cardiovascular risk, baseline weight, and baseline waist circumference.
SecondaryTime to Achieve the Target Blood Pressure From Baseline

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

Time frame:
14 Weeks
Reported as:
Median · Weeks
Time to Achieve the Target Blood Pressure From Baseline
WeeksLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Time to Achieve the Target Blood Pressure From Baseline7.43 (6.24 to 8.62)6.57 (6.29 to 6.85)
Statistical analysis
  • Losartan-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group) · Log Rank · p = 0.212

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Losartan-Based Regimen Alone (L Group)—13/531 (2.4%)55/531 (10.4%)
Diet Management and Losartan-Based Regimen (DML Group)—10/453 (2.2%)46/453 (10.2%)
Most frequent serious events
Showing 10 of 33
Most frequent serious events
EventLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
Acute myocardial infarctionCardiac disorders0/5312/453
Myocardial infarctionCardiac disorders0/5312/453
PalpitationsCardiac disorders0/5311/453
Supraventricular tachycardiaCardiac disorders0/5311/453
TachycardiaCardiac disorders0/5311/453
Dry mouthGastrointestinal disorders0/5311/453
InflammationGeneral disorders0/5311/453
AmyloidosisImmune system disorders0/5311/453
GastroenteritisInfections and infestations0/5311/453
PneumoniaInfections and infestations0/5311/453
Most frequent other events
Showing 10 of 87
Most frequent other events
EventLosartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)
DizzinessNervous system disorders11/5316/453
HeadacheNervous system disorders7/5316/453
HypotensionVascular disorders6/5312/453
FatigueGeneral disorders4/5312/453
NauseaGastrointestinal disorders2/5313/453
Upper respiratory tract infectionInfections and infestations0/5313/453
CoughRespiratory, thoracic and mediastinal disorders1/5313/453
DiarrhoeaGastrointestinal disorders3/5312/453
Drug hypersensitivityImmune system disorders3/5310/453
MyalgiaMusculoskeletal and connective tissue disorders3/5312/453

Baseline characteristics

Age, Continuous
Age, Continuous(years)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
Mean56.05 ± 11.5454.59 ± 11.9855.38 ± 11.76
Sex: Female, Male
Sex: Female, Male(Participants)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
Female239208447
Male224192416
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
White404369773
Black9413
Hispanic213
Asian382058
Native Indian325
Other7411
Cardiovascular Risk
Cardiovascular Risk(Participants)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
High11292204
Medium9461155
Low218216434
Not Available352762
Missing448
Diastolic Blood Pressure
Diastolic Blood Pressure(mm Hg)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
Mean90.67 ± 9.1991.43 ± 9.9891.02 ± 9.57
Systolic Blood Pressure
Systolic Blood Pressure(mm Hg)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
Mean151.23 ± 10.80151.11 ± 12.55151.17 ± 11.64
Weight
Weight(Kilograms)Losartan-Based Regimen Alone (L Group)Diet Management and Losartan-Based Regimen (DML Group)Total
Mean85.41 ± 19.9589.17 ± 20.1887.16 ± 20.13
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
NCT00739674
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 22, 2008
Start date
Feb 1, 2008
Primary completion
Jul 1, 2009
Completion
Jan 1, 2010
Results posted
Aug 11, 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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