Clinical trial

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.

Name

0954A-335

Description

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.

Trial arms

Trial start

2008-02-01

Estimated PCD

2009-07-01

Trial end

2010-01-01

Status

Completed

Phase

Early phase I

Treatment

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

Arms:

Diet Management and Losartan-Based Regimen (DML Group), Losartan-Based Regimen Alone (L Group)

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:

Diet Management and Losartan-Based Regimen (DML Group)

Size

992

Primary endpoint

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

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 992, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

1 product

1 indication

Organization

Organon and Co

Product

Losartan

Indication

Hypertension