SAALT: Subtracting Salt and Adding Losartan Trial (0954-335)(COMPLETED) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00739674

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: losartan potassium (+ hydrochlorothiazide [HCTZ] + calcium channel blocker [CCB]) Behavioral: Low Salt Diet	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Open-label Trial to Evaluate the Effectiveness of Diet Management With a Losartan Titration Regimen Versus Losartan Titration Regimen Alone on Blood Pressure Reduction in Hypertensives.

Resource links provided by NLM:

MedlinePlus related topics: Dietary Sodium High Blood Pressure Potassium

Drug Information available for: Hydrochlorothiazide Calcium Gluconate Sodium chloride Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Number of Patients Achieving Target Blood Pressure at Week 14 From Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
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
Change in Systolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Change in Diastolic Blood Pressure From Baseline to Week 14 [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Patients Achieving Target Blood Pressure at Week 6 From Baseline [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
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
Number of Patients Achieving Target Blood Pressure at Week 10 From Baseline [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
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
Number of Patients Achieving Target Blood Pressure at Week 40 From Baseline [ Time Frame: 40 Weeks ] [ Designated as safety issue: No ]
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
Change in Systolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Change in Diastolic Blood Pressure From Baseline to Week 6 [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
Change in Systolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Change in Diastolic Blood Pressure From Baseline to Week 10 [ Time Frame: 10 Weeks ] [ Designated as safety issue: No ]
Time to Achieve the Target Blood Pressure From Baseline [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Time to achieve the target blood pressure (<140/90 mm Hg and <130/80 mm Hg for diabetics).

Enrollment:	992
Study Start Date:	February 2008
Study Completion Date:	January 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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]) 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
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]) 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 Behavioral: Low 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)

Arms

Assigned Interventions

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])

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

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])

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

Behavioral: Low 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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739674

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00739674 History of Changes
Other Study ID Numbers:	MK0954A-335, 2008_022
Study First Received:	August 20, 2008
Results First Received:	July 14, 2010
Last Updated:	November 4, 2010
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Hydrochlorothiazide
Losartan
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents

Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2012