Arterial hypertension Circulatory System Essential (primary) hypertension
Conditions
Interventions
Data from 2,000 individuals who start their drug therapy for arterial hypertension by taking telsartan or telsartan H in the therapeutically recommended dose range for 12 weeks will be used to examine
Sponsors
Dr. Reddy’s Laboratories (Russia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. ICF signed prior to enrollment 2. Hypertension diagnosis verified 3. Office SBP >140 mmHg and/or office DBP >90 mmHg 4. Absence or inefficacy of antihypertensive treatment prior to enrollment 5. Decision of telmisartan prescription as monotherapy or in combination with hydrochlorothiazide/amlodipine was taken by the physician prior to enrollment
Exclusion criteria
Exclusion criteria: 1. Telmisartan treatment during 90 days prior to enrollment 2. Malignant hypertension 3. Secondary hypertension 4. Refuse to monitor BP by patient 5. Pregnancy and lactation period 6. Any condition that could alter patient safety or protocol procedures during the course of study 7. Any condition that by physician’s decision could stop from patient enrollment 8. Hypersensitivity, significant ADRs or contraindications for telmisartan treatment 9. Refusal to follow the physician’s instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Demographic, lifestyle and clinical characteristics: 1.1. BMI kg/m² data obtained from source documents at Visit 1 1.2. Status of smoking measured using medical history data in source documents and information obtained from the patient at Visit 1 1.3. Alcohol consumption measured using medical history data in source documents and information obtained from the patient at Visit 1 1.4. Sedentary lifestyle measured using medical information obtained from the patient at Visit 1 1.5. Cardiovascular risk measured using SCORE assessment at Visit 1 2. Patient self-measurement of blood pressure using home blood pressure monitoring (HBPM) from baseline to endpoint 3. Office blood pressure measurement by medical personnel from baseline to endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability of the therapy measured as the number of patients with adverse reactions and the incidence of different adverse reactions at 12 weeks 2. Course of hypertension-induced renal damage by assessing the following after 12 weeks of treatment: 2.1. Creatinine blood level 2.2. Estimated glomerular filtration rate (eGFR) 2.3. Urinary excretion of albumin 3. Rate (%) of adherence to the initial treatment measured using patient self-report at 12 weeks 4. In the subpopulation reporting headache at baseline, headache symptoms measured using the headache inventory at baseline and 12 weeks 5. Number of patients with controlled AH (continuous maintenance of target blood pressure according to 2013 ESC guidelines) at 12 weeks 6. Patients’ satisfaction with their treatment as measured by patient diary at baseline and the end of 12 weeks of telmisartan treatment 7. Health-related quality of life (HRQOL) measured at baseline and 12 weeks by: 7.1. SF-36 Health Survey summary 7.2. Likert scale score assessing the changes in patient's daily life | — |
Countries
Russian Federation
Outcome results
None listed