Essential Hypertension
Conditions
Keywords
Hypertension, ambulatory blood pressure, missed dose, aliskiren
Brief summary
The purpose of this study is to investigate the efficacy (blood pressure lowering effect) and safety of aliskiren given to hypertensive patients after a missed dose.
Interventions
DRUGAliskiren
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 before application of Ambulatory Blood Pressure Measurement device At Visit 3 : 24-hr Mean Ambulatory Diastolic Blood Pressure ≥ 85 mmHg * Patient must have an absolute difference of ≤ 10 mmHg in their office Mean Sitting Diastolic Blood Pressure between Visit 2 and 3. * Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation. * 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 informed consent).
Exclusion criteria
* Severe hypertension \[Office Mean Sitting Diastolic Blood Pressure ≥ 110 mmHg and/or office mean sitting systolic blood pressure (MSSBP) ≥ 180 mmHg\]. * Current diagnosis of heart failure (NYHA Class II-IV). * History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. * Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors or ARBs. * Upper arm circumference \> 42 cm. * Third shift or night workers. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, aliskiren 300 mg versus irbesartan 300mg. | — |
| from baseline. | — |
| Mean 24-hour ambulatory diastolic blood pressure (MADBP) change from baseline, after a missed dose, ramipril 10 mg versus irbesartan 300mg. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy on the MASBP and MADBP change from baseline following the last active dose prior to introducing a missed dose in any treatment group. | — |
| efficacy on mean 24 hour ambulatory systolic blood pressure (MASBP) change | — |
| safety and tolerability | — |
| efficacy on the daytime and nighttime MASBP and MADBP change from baseline, following the last active dose prior to introducing a missed dose in any treatment group. | — |
| from baseline following a missed dose | — |
| efficacy on daytime and nighttime MASBP and MADBP change from baseline following a missed dose | — |
Countries
Germany, Switzerland
Outcome results
None listed