SEVIKAR HCT - treatment opportunity for patients with essential hypertension (SeviTarget)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-Interventional Post-Authorisation Safety Study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OLMESARTAN MEDOXOMIL

  AMLODIPINE BESILATE

  HYDROCHLOROTHIAZIDE
• Medical condition to be studied:
  Essential hypertension

Population studied

• Short description of the study population:
  Consecutive male and female adult patients with diagnosis of essential hypertension who had started SEVIKAR HCT® therapy less than 2 weeks before patients’ Baseline visit (V1).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Essential hypertension patients
• Estimated number of subjects:
  6600

Study design details

• Main study objective:
  Primary objective: To further investigate the safety profile of SEVIKAR HCT in daily practice and to collect data on so far unexpected adverse reactions as well as possible interactions with concomitant medications.
• Outcomes:
  Adverse Drug Reactions, Secondary objectives: Efficacy within each of the SEVIKAR HCT dose regimens in daily practice using various blood pressure related parameters and response criteria / Patient compliance / Patient reported outcome / Physicians' judgement of tolerability and efficacy
• Data analysis plan:
  All variables collected in the CRF and all derived parameters will be used in statistical analysis. Binary, categorical and ordinal parameters will be summarized by means of absolute and percentage numbers within the various categories. Numerical data will be summarized by means of summary statistics (presented by visit, if useful). Pre-post differences will be calculated as post-baseline value minus baseline value. In addition, adequate figures (e.g. bar charts, box-whisker plots) may be presented to summarize the results for some parameters in a graphical way. Two-sided confidence intervals (CI) will be presented for important parameters, but should be interpreted in an exploratory descriptive way. No formal statistical tests will be performed within the statistical analysis. Depending on the variables of interest, additional selection criteria for patients (e.g. sub-group analyses) considered in specific analyses may be used, if considered useful during the statistical analysis.

Documents

Study results

20141209_SeviTarget_NIS Report Final v1 0

Study publications

Bramlage P, Fronk EM, Wolf WP, Smolnik R et al. Safety and effectiveness of a f…