None listed
Conditions
Interventions
Intervention1: Aliskiren: Aliskiren (150 mg or 300 mg) or aliskiren HCT SPC (150mg/12.5 mg, 300mg/12.5 mg) administered
As monotherapy, respectively SPC therapy, or as add-on therapy to diuretics, B
Sponsors
Novartis Healthcare Pvt. Limited, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli , Mumbai - 400018. Ph: +91 22 2498 8888, Fax: +91 22 2495 4112
Eligibility
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill the following criteria: 1. Male and female outpatients, aged &#8805; 18 years with established diagnosis of hypertension, for whom treatment with aliskiren or aliskiren HCT is medically recommended. 2. Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care. Aliskiren or aliskiren HCT can be administered as monotherapy, respectively SPC therapy (first antihypertensive treatment or switch from a previous treatment), or as add-on therapy and should be in adherence with the prescribing information (Summary of product characteristics). Treatment with aliskiren or aliskiren HCT SPC is medically recommended for patients with established diagnosis of hypertension (DBP- 90mmHg and/or SBP- 140mmHg) under current antihypertensive medication, and/or unacceptable side effects caused by their current antihypertensive medication. For high risk patients with type 1 or 2 diabetes, best practice guidelines (10) recommend DBP<80mmHg and SBP<130mmHg, however we leave it to the prescribing physician to determine at which point to initiate treatment. The indication for the administration of aliskiren or aliskiren HCT SPC, as well as contraindications and possible side effects have to be considered and can be taken from the Summary of Product Characteristics. The therapy shall not be prescribed for the purpose of entering a patient in this observational study, but solely based on clinical judgement of the treating physician.
Exclusion criteria
Exclusion criteria: Contraindications mentioned in the local Summary of Product Characteristics for aliskiren or aliskiren HCT SPC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess effectiveness of , aliskiren and aliskiren HCT SPC as anti-hypertensive therapy (monotherapy, respectively SPC therapy, or as add-on therapy) under daily life conditions during a planned observation and treatment period of at least 26 weeks (6 months) To assess safety and tolerability of aliskiren and aliskiren HCT as anti-hypertensive therapy (monotherapy, respectively SPC therapy, or as add-on therapy) under daily life conditions during a planned observation and treatment period of at least 26 weeks (6 months) Timepoint: The observational period of 26 ± 8 weeks covers at least 2 examinations for each patient according to the routine in daily practice. In case of discontinuation or interruption of treatment, the reason has to be given. Baseline Visit: Each patient will attend one baseline visit (Visit 1) where the inclusion/exclusion criteria will be assessed. Patients who meet all inclusion and no exclusion criteria will enter into this study. The hypertensive patients will be treated according to the local medication label and current practice. Observation Period: The observation period will be 26 ± 8 weeks. At the discretion, and as per routine practice, of the treating physician an optional visit with data collection after about 13 weeks of treatment may be conducted. Final Visit: A final study visit at 26 ± 8 weeks is required. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess patient adherence to treatment To assess the effect on (micro-)albuminuria (optional) Timepoint: The observational period of 26 ± 8 weeks covers at least 2 examinations for each patient according to the routine in daily practice. In case of discontinuation or interruption of treatment, the reason has to be given. Baseline Visit: Each patient will attend one baseline visit (Visit 1) where the inclusion/exclusion criteria will be assessed. Patients who meet all inclusion and no exclusion criteria will enter into this study. The hypertensive patients will be treated according to the local medication label and current practice. Observation Period: The observation period will be 26 ± 8 weeks. At the discretion, and as per routine practice, of the treating physician an optional visit with data collection after about 13 weeks of treatment may be conducted. Final Visit: A final study visit at 26 ± 8 weeks is required. | — |
Countries
India
Contacts
Public ContactDr. Pramod Gawli
Outcome results
None listed