Phase
Condition
High Blood Pressure (Hypertension)
High Blood Pressure (Hypertension - Pediatric)
Stress
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Outpatients 18 years of age and older.
Patients must meet following blood pressure criteria: At Visit 2 : Office Mean Sitting Diastolic Blood Pressure ≥ 90 mmHg and < 110 mmHg At Visit 3 : Office Mean Sitting Diastolic Blood Pressure ≥ 95 mmHg and < 110 mmHg beforeapplication of Ambulatory Blood Pressure Measurement device At Visit 3 : 24-hr MeanAmbulatory Diastolic Blood Pressure ≥ 85 mmHg
Patient must have an absolute difference of ≤ 10 mmHg in their office Mean SittingDiastolic Blood Pressure between Visit 2 and 3.
Male or female patients are eligible. Female patients must be either post-menopausalfor at least one year, surgically sterile or using effective contraceptive methodssuch as oral contraceptives, barrier method with spermicide or an intrauterine device.Reliable contraception should be maintained throughout the study and for 7 days afterstudy drug discontinuation.
Patients who are eligible and able to participate in the study, and who consent to doso after the purpose and nature of the investigation has been clearly explained tothem (written informed consent).
Exclusion
Exclusion Criteria:
Severe hypertension [Office Mean Sitting Diastolic Blood Pressure ≥ 110 mmHg and/oroffice mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg].
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneouscoronary intervention (PCI) during the 12 months prior to Visit 1.
Known or suspected contraindications to the study medications, including history ofallergy to ACE-Inhibitors or ARBs.
Upper arm circumference > 42 cm.
Third shift or night workers. Other protocol-defined inclusion/exclusion criteria may apply
Study Design
Connect with a study center
Investigative Centers,
GermanySite Not Available
Novartis Pharmaceuticals
Basel,
SwitzerlandSite Not Available
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