Trial · NCT00739674
SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
NCT00739674, Phase 3, Completed, Organon and Co; results first posted 2010-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335). Trials, record NCT00739674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00739674
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SAALT: Subtracting Salt and Adding Losartan Trial (0954A-335)
- NCT number
- NCT00739674
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 992 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypertension
- Interventions
- losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]), Low Salt Diet
- First posted
- 2008-08-22
- Last updated
- 2024-05-16
- Results first posted
- 2010-08-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline | 14 Weeks | 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 |
| Primary | Change in Systolic Blood Pressure From Baseline to Week 14 | 14 Weeks | |
| Primary | Change in Diastolic Blood Pressure From Baseline to Week 14 | 14 Weeks | |
| Secondary | Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline | 6 Weeks | 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 |
| Secondary | Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline | 10 Weeks | 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 |
| Secondary | Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline | 40 Weeks | 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 |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 6 | 6 Weeks | |
| Secondary | Change in Diastolic Blood Pressure From Baseline to Week 6 | 6 Weeks | |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 10 | 10 Weeks | |
| Secondary | Change in Diastolic Blood Pressure From Baseline to Week 10 | 10 Weeks |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline | 14 Weeks | 463 and 400 - 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 357 patients at week 14 for L group and DML group respectively. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline | 6 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline | 10 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline | 40 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 351 and 331 patients at week 40 for L group and DML group respectively. | Participants | NUMBER |
| PRIMARY | Change in Systolic Blood Pressure From Baseline to Week 14 | 14 Weeks | 463 and 400 - 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 357 patients at week 14 for L group and DML group respectively. | mm Hg | MEAN |
| PRIMARY | Change in Diastolic Blood Pressure From Baseline to Week 14 | 14 Weeks | 463 and 400 - 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 357 patients at week 14 for L group and DML group respectively. | mm Hg | MEAN |
| SECONDARY | Change in Systolic Blood Pressure From Baseline to Week 6 | 6 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively. | mm Hg | MEAN |
| SECONDARY | Change in Diastolic Blood Pressure From Baseline to Week 6 | 6 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 431 and 383 patients at week 6 for L group and DML group respectively. | mm Hg | MEAN |
| SECONDARY | Change in Systolic Blood Pressure From Baseline to Week 10 | 10 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively. | mm Hg | MEAN |
| SECONDARY | Change in Diastolic Blood Pressure From Baseline to Week 10 | 10 Weeks | 463 and 400 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 399 and 370 patients at week 10 for L group and DML group respectively. | mm Hg | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline | Losartan-Based Regimen Alone (L Group) | Achieve Target Blood Pressure | 276 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline | Diet Management and Losartan-Based Regimen (DML Group) | Achieve Target Blood Pressure | 270 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline | Losartan-Based Regimen Alone (L Group) | Did not Achieve Target Blood Pressure | 116 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline | Diet Management and Losartan-Based Regimen (DML Group) | Did not Achieve Target Blood Pressure | 87 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline | Losartan-Based Regimen Alone (L Group) | Achieve Target Blood Pressure | 239 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline | Diet Management and Losartan-Based Regimen (DML Group) | Achieve Target Blood Pressure | 231 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline | Losartan-Based Regimen Alone (L Group) | Did not Achieve Target Blood Pressure | 192 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline | Diet Management and Losartan-Based Regimen (DML Group) | Did not Achieve Target Blood Pressure | 152 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline | Losartan-Based Regimen Alone (L Group) | Achieve Target Blood Pressure | 257 | Participants | |
| Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline | Diet Management and Losartan-Based Regimen (DML Group) | Achieve Target Blood Pressure | 254 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Losartan-Based Regimen Alone (L Group) | 535 | |
| Overall Study | STARTED | Diet Management and Losartan-Based Regimen (DML Group) | 457 | |
| Overall Study | Screening Failures | Losartan-Based Regimen Alone (L Group) | 19 | |
| Overall Study | Screening Failures | Diet Management and Losartan-Based Regimen (DML Group) | 17 | |
| Overall Study | Site 212 Removal | Losartan-Based Regimen Alone (L Group) | 19 | |
| Overall Study | Site 212 Removal | Diet Management and Losartan-Based Regimen (DML Group) | 13 | |
| Overall Study | No Follow-up Data | Losartan-Based Regimen Alone (L Group) | 33 | |
| Overall Study | No Follow-up Data | Diet Management and Losartan-Based Regimen (DML Group) | 18 | |
| Overall Study | Dietician Consultation >30 Days | Losartan-Based Regimen Alone (L Group) | 1 | |
| Overall Study | Dietician Consultation >30 Days | Diet Management and Losartan-Based Regimen (DML Group) | 9 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events240
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 | Lymphadenopathy | Blood and lymphatic system disorders | Losartan-Based Regimen Alone (L Group) | 0 | 531 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Diet Management and Losartan-Based Regimen (DML Group) | 1 | 453 | 1 |
| other | Arrhythmia | Cardiac disorders | Losartan-Based Regimen Alone (L Group) | 0 | 531 | |
| other | Arrhythmia | Cardiac disorders | Diet Management and Losartan-Based Regimen (DML Group) | 1 | 453 | 1 |
| other | Palpitations | Cardiac disorders | Losartan-Based Regimen Alone (L Group) | 1 | 531 | 1 |
| other | Palpitations | Cardiac disorders | Diet Management and Losartan-Based Regimen (DML Group) | 0 | 453 | |
| other | Eye irritation | Eye disorders | Losartan-Based Regimen Alone (L Group) | 1 | 531 | 1 |
| other | Eye irritation | Eye disorders | Diet Management and Losartan-Based Regimen (DML Group) | 0 | 453 | |
| other | Vision blurred | Eye disorders | Losartan-Based Regimen Alone (L Group) | 1 | 531 | 1 |
| other | Vision blurred | Eye disorders | Diet Management and Losartan-Based Regimen (DML Group) | 0 | 453 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan-Based Regimen Alone (L Group) | ||
| Total, all-cause mortality | Diet Management and Losartan-Based Regimen (DML Group) | ||
| Total, other adverse events | Losartan-Based Regimen Alone (L Group) | 55 | 531 |
| Total, other adverse events | Diet Management and Losartan-Based Regimen (DML Group) | 46 | 453 |
| Total, serious adverse events | Losartan-Based Regimen Alone (L Group) | 13 | 531 |
| Total, serious adverse events | Diet Management and Losartan-Based Regimen (DML Group) | 10 | 453 |
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-Based Regimen Alone (L Group) vs Diet Management and Losartan-Based Regimen (DML Group): 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.
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/NCT00739674
GET https://conductscience.org/api/trials/v1/NCT00739674/results?page=2