Aliskiren in Hypertension: Efficacy and sAfety stuDy (AHEAD)

Phase 4

• Registration Number: CTRI/2010/091/000645
• Lead Sponsor: ovartis Healthcare Pvt. Limited, Sandoz House, Shivsagar Estate, Dr. Annie Besant Road, Worli , Mumbai - 400018. Ph: +91 22 2498 8888, Fax: +91 22 2495 4112

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill the following criteria:
1. Male and female outpatients, aged ≥ 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

Contraindications mentioned in the local Summary of Product Characteristics for aliskiren or aliskiren HCT SPC

Study & Design

• Study Type: Interventional
• Study Design: Not specified