Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
Phase 3
Completed
- Conditions
- Hypertension; Hypertrophy, Left Ventricular
- Interventions
- Registration Number
- NCT00446563
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
- Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
- Patients with Left Ventricular Hypertrophy
Exclusion Criteria
- Severe hypertension
- Symptomatic heart failure
- History of stroke, heart attack, coronary bypass surgery etc.
- Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Losartan + Hydrochlorothiazide Hydrochlorothiazide Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. Amlodipine + Valsartan Amlodipine Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. Amlodipine + Valsartan Valsartan Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. Losartan + Hydrochlorothiazide Losartan Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
- Primary Outcome Measures
Name Time Method Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) Baseline to week 52
- Secondary Outcome Measures
Name Time Method Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI Baseline to week 52 Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI Baseline to week 52 Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI Baseline to week 52 Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP) Baseline to week 52 Percentage of Participants Achieving Target Blood Pressure at Week 52 Week 52 Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) \< 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) \< 90 mm Hg.
Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI Baseline to week 52 Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI Baseline to week 52 Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI Baseline to week 52 Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) Baseline to week 52 Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI Baseline to week 52 Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI Baseline to week 52 Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI Baseline to week 52 Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI Baseline to week 52 Percentage of Participants Who Experienced Adverse Events (AEs) Baseline to week 52 An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.
Trial Locations
- Locations (1)
25 centers in Germany
🇩🇪Ludwigshafen, Germany