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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00739674
First received: August 20, 2008
Last updated: November 14, 2013
Last verified: November 2013
Results First Received: July 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])
Behavioral: Low Salt Diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First patient in: FEB-05-2008

Last patient out: JAN-15-2010

Total number of sites: 109 sites in Canada


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Losartan-Based Regimen Alone (L Group) Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including hydrochlorothiazide (HCTZ) 12.5 mg or 25 mg and calcium channel blocker (CCB) as needed to achieve target blood pressure.
Diet Management and Losartan-Based Regimen (DML Group) Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt Dietary Approaches to Stop Hypertension (DASH) diet management.

Participant Flow:   Overall Study
    Losartan-Based Regimen Alone (L Group)     Diet Management and Losartan-Based Regimen (DML Group)  
STARTED     535     457  
Screening Failures     19     17 [1]
Site 212 Removal     19 [2]   13 [2]
No Follow-up Data     33     18  
Dietician Consultation >30 Days     1 [3]   9 [3]
Intent-to-treat (ITT) Population     463 [1]   400 [1]
COMPLETED     354     335  
NOT COMPLETED     181     122  
Screening failures                 19                 17  
Site 212 removal                 19                 13  
No follow-up data                 33                 18  
Dietician consultation >30 days                 1                 9  
Adverse Event                 22                 13  
Death                 1                 0  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 52                 30  
Protocol Violation                 5                 5  
Withdrawal by Subject                 9                 9  
Reason missing                 2                 0  
Clinic closed                 6                 4  
Patient moved                 3                 2  
Non compliant                 4                 0  
Unable to attend visit                 3                 1  
Home monitoring off meds                 1                 0  
Erectile dysfunction                 0                 1  
[1] ITT population took at least one dose of the study medication and had one follow-up visit.
[2] lack of source documentation & frequent discrepancies between source notes and case report entries.
[3] Patients with dietician consultations >30 days after visit 1 were not included in the data analysis.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Losartan-Based Regimen Alone (L Group)

Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.

The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).

Diet Management and Losartan-Based Regimen (DML Group)

Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure combined with low-salt DASH diet management.

The Baseline Measures are reported for the Intent-to-treat (ITT) population (i.e. took at least one dose of the study medication and returned for one follow-up visit).

Total Total of all reporting groups

Baseline Measures
    Losartan-Based Regimen Alone (L Group)     Diet Management and Losartan-Based Regimen (DML Group)     Total  
Number of Participants  
[units: participants]
  463     400     863  
Age  
[units: years]
Mean ± Standard Deviation
  56.05  ± 11.54     54.59  ± 11.98     55.38  ± 11.76  
Gender  
[units: participants]
     
Female     239     208     447  
Male     224     192     416  
Race/Ethnicity, Customized  
[units: participants]
     
White     404     369     773  
Black     9     4     13  
Hispanic     2     1     3  
Asian     38     20     58  
Native Indian     3     2     5  
Other     7     4     11  
Cardiovascular Risk [1]
[units: Participants]
     
High     112     92     204  
Medium     94     61     155  
Low     218     216     434  
Not Available     35     27     62  
Missing     4     4     8  
Diastolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  90.67  ± 9.19     91.43  ± 9.98     91.02  ± 9.57  
Systolic Blood Pressure  
[units: mm Hg]
Mean ± Standard Deviation
  151.23  ± 10.80     151.11  ± 12.55     151.17  ± 11.64  
Weight  
[units: Kilograms]
Mean ± Standard Deviation
  85.41  ± 19.95     89.17  ± 20.18     87.16  ± 20.13  
[1] Cardiovascular Risk according to Framingham Equation



  Outcome Measures
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1.  Primary:   Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline   [ Time Frame: 14 Weeks ]

2.  Primary:   Change in Systolic Blood Pressure From Baseline to Week 14   [ Time Frame: 14 Weeks ]

3.  Primary:   Change in Diastolic Blood Pressure From Baseline to Week 14   [ Time Frame: 14 Weeks ]

4.  Secondary:   Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline   [ Time Frame: 6 Weeks ]

5.  Secondary:   Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline   [ Time Frame: 10 Weeks ]

6.  Secondary:   Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline   [ Time Frame: 40 Weeks ]

7.  Secondary:   Change in Systolic Blood Pressure From Baseline to Week 6   [ Time Frame: 6 Weeks ]

8.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 6   [ Time Frame: 6 Weeks ]

9.  Secondary:   Change in Systolic Blood Pressure From Baseline to Week 10   [ Time Frame: 10 Weeks ]

10.  Secondary:   Change in Diastolic Blood Pressure From Baseline to Week 10   [ Time Frame: 10 Weeks ]

11.  Secondary:   Time to Achieve the Target Blood Pressure From Baseline   [ Time Frame: 14 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00739674     History of Changes
Other Study ID Numbers: 0954A-335, 2008_022, MK0954A-335
Study First Received: August 20, 2008
Results First Received: July 14, 2010
Last Updated: November 14, 2013
Health Authority: Canada: Health Canada