Clareo Health | Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Outpatients 18-75 years of age.
Male or female patients are eligible.
Patients with a diagnosis of hypertension:
Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a mean sitting systolic blood pressure (MSSBP) \> 150 mmHg and \< 180 mmHg at Visit 1.
Patients treated with antihypertensive monotherapy must have a MSSBP ≥ 140 mmHg and \<180 mmHg at Visit 1.
Patients taking amlodipine monotherapy MSSBP \> 140 mmHg and \< 180 mmHg at visit 1.
All patients must have a MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 3, the end of the amlodipine run-in period.
Metabolic syndrome.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form).
History or evidence of a secondary form of hypertension.
History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Serum sodium \< 135 mmol/L at Visit 1 if confirmed on repeat sample.
Serum potassium \< 3.5 mmol/L or ≥ 5.3 mmol/L at Visit 1, if confirmed on repeat sample.
Type 1 diabetes mellitus.
Type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication change) in previous 3 months.
