Essential Hypertension
Conditions
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients must give written informed consent before any assessment is performed - Patients with essential hypertension, untreated or currently taking antihypertensive therapy must have a mean sitting systolic blood pressure(msSBP) >= 150 mmHg and < 180 mmHg - Patients must be able to communicate and comply with all study requirements and demonstrate good medication compliance
Exclusion criteria
Exclusion criteria: - Patients with severe hypertension. Patients with history of angioedema, drug-related or otherwise - Patients with history or evidence of a secondary form of hypertension - Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke - History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1 - Current angina pectoris requiring medication (other than patients on a stable dose of oral or topical nitrates) - Patients with Type 1 or Type 2 diabetes mellitus who are not well controlled and are not on a stable dose of antidiabetic medication - Patients with previous or current diagnosis of heart failure (NYHA Class II-IV) - Patients with a clinically significant valvular heart disease at the time of screening - Women of child-bearing potential, who do not use adequate birth control methods Other protocol-defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in msSBP at week 10 Sitting BP measurements will be performed at trough (immediately prior to dosing at the clinic). At study entry BP should be measured in both arms. The arm with the higher SBP reading should be used for the 4 measurements at screening visit and the same arm should be used at all subsequent visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in mean 24 hour ambulatory systolic blood pressure (maSBP) at week 10 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm. Change from baseline in msSBP and mean sitting diastolic blood pressure (msDBP) at week 4 and week 14 Sitting BP measurements will be performed at trough (immediately prior to dosing at the clinic). At study entry BP should be measured in both arms. The arm with the higher SBP reading should be used for the 4 measurements at screening visit and the same arm should be used at all subsequent visits. Change in baseline in mean 24 hour ambulatory diastolic blood pressure (maDBP) at week 10 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm. Change from baseline in msDBP at week 10 Sitting BP measurements will be performed at trough (immediately prior to dosing at the clinic). At study entry BP should be measured in both arms. The arm with the higher SBP reading should be used for the 4 measurements at screening visit and the same arm should be used at all subsequent visits. Office pulse pressure measurement at week 4, week 10 and week 14 Pulse pressure will be calculated msSBP/msDBP which measured by automated BP device at each visit. Change from baseline in daytime and nighttime maSBP/maDBP at week 10 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-dominant arm. Change from baseline in maSBP and maDBP for daytime/nighttime at week 10 ABPM over a 24-hour period will be conducted at two time-points during the study in a subset of patients. Readings will be taken every 20 minutes over the 24 hour period in the non-domi | — |
Outcome results
None listed