SAALT: Subtracting Salt and Adding Losartan Trial (0954A-... | NCT00739674

NCT00739674

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Losartan-Based Regimen Alone (L Group)	Active Comparator	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])
Diet Management and Losartan-Based Regimen (DML Group)	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB])	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	14 Weeks
Change in Systolic Blood Pressure From Baseline to Week 14		14 Weeks
Change in Diastolic Blood Pressure From Baseline to Week 14		14 Weeks

Secondary Outcomes

Measure	Description	Time Frame
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	6 Weeks
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline

Eligibility Module

Eligibility Criteria

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:

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

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000535 subjects FG001457 subjects
Screening Failures		FG00019 subjects FG00117 subjectsITT population took at least one dose of the study medication and had one follow-up visit.
Site 212 Removal		FG00019 subjectslack of source documentation \& frequent discrepancies between source notes and case report entries. FG00113 subjectslack of source documentation \& frequent discrepancies between source notes and case report entries.
No Follow-up Data		FG00033 subjects FG00118 subjects
Dietician Consultation >30 Days		FG0001 subjectsPatients with dietician consultations \>30 days after visit 1 were not included in the data analysis. FG0019 subjectsPatients with dietician consultations \>30 days after visit 1 were not included in the data analysis.
Intent-to-treat (ITT) Population		FG000463 subjectsITT population took at least one dose of the study medication and had one follow-up visit. FG001400 subjectsITT population took at least one dose of the study medication and had one follow-up visit.
COMPLETED		FG000354 subjects FG001335 subjects
NOT COMPLETED		FG000181 subjects FG001122 subjects

Type	Comment	Reasons
Screening failures		FG00019 subjects FG00117 subjects
Site 212 removal		FG00019 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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).

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

Posted

Number

Participants

14 Weeks

ID	Title	Description
OG000	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.
OG001	Diet Management and Losartan-Based Regimen (DML Group)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D019808	Losartan
D006852	Hydrochlorothiazide
D002121	Calcium Channel Blockers
D004039	Diet, Sodium-Restricted

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

ID	Type	Description	Link
2008_022
MK0954A-335