Study of the safety and efficacy of LCZ696 on arterial stiffness in elderly patients with hypertensio
- Conditions
- elderly Hypertensive patientsMedDRA version: 14.1Level: PTClassification code 10020772Term: HypertensionSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 14.1Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-002899-14-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 432
• Written informed consent must be obtained before any assessment is performed • Male and female patients = 60 years of age. • Patients with essential hypertension, untreated or currently taking antihypertensive therapy. • Untreated patients must have an office msSBP =150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1. • Treated patients must have an office msSBP =140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP =150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1. • All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP. • Patients must have a difference in msSBP of +/-15 mmHg betweenv Visit 201 (randomization) and the visit immediately prior to Visit 201. • Patients with the ability to communicate and comply with all study requirements and demonstrate good medication compliance (=80% compliance rate) during the run-in epoch (Epoch 2).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 332
Malignant or severe hypertension (grade 3 of WHO classification; msDBP =110 mmHg and/or msSBP =180 mmHg). History of angioedema, drug-related or otherwise. 4. History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension. 5. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke. 6. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 7. Current angina pectoris requiring pharmacological therapy (other than patients on a stable dose of oral or topical nitrates). 8. Type 1 or Type 2 diabetes mellitus not well controlled based on the investigator's clinical judgment. Patients currently being treated for diabetes mellitus should be on stable dose of anti-diabetic medication for at least 4 weeks prior to Visit 1. 9. Previous or current diagnosis of heart failure (NYHA Class II-IV). 10. Clinically significant valvular heart disease at Visit 1. 11. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at Visit 101. 12. History or current diagnosis of the following cardiac abnormalities: • Second or third degree AV block without a pacemaker. • History of familial long QT syndrome or family history of torsade de pointe....
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate superiority of an LCZ696 regimen compared to an olmesartan regimen, as measured by change from baseline in mean Central Aortic Systolic Blood Pressure (CASP) after 12 weeks of treatment in elderly patients with essential hypertension.;Secondary Objective: Key Secondary Objective: To demonstrate superiority of an LCZ696 regimen compared to an olmesartan regimen, as measured by change from baseline in mean Central Pulse Pressure (CPP) after 12 weeks of treatment.;Primary end point(s): The primary endpoint for this phase 2 study is change from baseline in central aortic systolic pressure (CASP) after 12 weeks of treatment with LCZ696 (4 weeks of 200 mg with an additional 8 weeks of 400 mg) or olmesartan (4 weeks of 20 mg with an additional 8 weeks of 40 mg).;Timepoint(s) of evaluation of this end point: primary endpoint at Week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from baseline in mean central pulse pressure 2. Change from baseline in mean aortic pulse wave velocity 3. Change from baseline in mean central aortic systolic blood pressure at 52 weeks 4. Change from baseline in mean sitting systolic blood pressure 5. Change from baseline in mean sitting diastolic blood pressure 6. Change from baseline in mean sitting pulse pressure 7. Change from baseline in mean arterial pressure 8. Change from baseline in mean 24-hour systolic blood pressure 9. Change from baseline in mean 24-hour diastolic blood pressure 10. Change from baseline in mean 24-hour ambulatory pulse pressure;Timepoint(s) of evaluation of this end point: baseline, 12 weeks, and 52 weeks (1, 2, 4, 5, 6, 7, 8, 9, 10) baseline, 52 weeks (3)