Hypertension; Hypertrophy, Left Ventricular Clinical Trial
Official title:
An Open-label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension
| Verified date | May 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | 25 centers in Germany | Ludwigshafen |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) | Baseline to week 52 | No | |
| Secondary | 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 | No | |
| Secondary | Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI | Baseline to week 52 | No | |
| Secondary | Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI | Baseline to week 52 | No | |
| Secondary | Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI | Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat. | Baseline to week 52 | No |
| Secondary | Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI | Baseline to week 52 | No | |
| Secondary | 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 | No | |
| Secondary | Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI | Baseline to week 52 | No | |
| Secondary | 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 | No | |
| Secondary | Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI | Baseline to week 52 | No | |
| Secondary | Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI | Baseline to week 52 | No | |
| Secondary | Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP) | Baseline to week 52 | No | |
| Secondary | Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP) | Baseline to week 52 | No | |
| Secondary | Percentage of Participants Achieving Target Blood Pressure at 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. | Week 52 | No |
| Secondary | Percentage of Participants Who Experienced Adverse Events (AEs) | 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. | Baseline to week 52 | Yes |