Hypertension
Conditions
Keywords
hypertension, aliskiren, hydrochlorothiazide
Brief summary
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
Interventions
DRUGaliskiren
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study. 2. absence of ongoing severe adverse events at Visit 10.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months | — |
| Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months | — |
| Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months | — |
| Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline | — |
| Blood pressure less than 140/90 mmHg | — |
Countries
Belgium, Canada, Germany, Italy, Netherlands, Peru, Russia, Switzerland, United Kingdom, United States
Outcome results
None listed