N/A
Completed N=1,945
International Multicenter, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Participants With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan
Source: ClinicalTrials.gov NCT02756819 ↗Enrolled (actual)
1,945
Serious AEs
0.3%
Results posted
Nov 2019
Primary outcomePrimary: Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 — 156.8; -30.5 mmHg — p=<0.001
Summary
The purpose of this study is to estimate antihypertensive effect of azilsartan medoxomil (Edarbi®) therapy on blood pressure in participants with overweight or obesity in routine clinical practice of hypertension (HTN) treatment in the Russian Federation and in the Republic of Kazakhstan..
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 |
156.8; -30.5 | <0.001 sig |
| SECONDARY Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6 |
-14 | <0.001 sig |
| SECONDARY Percentage of Participants With Response at Month 6 |
92.6 | — |
| SECONDARY Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg |
86.4 | — |
| SECONDARY Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 |
-30.2; -30.6; -31.5; -27.1; -30.5; -30.1 | <0.001 sig |
| SECONDARY Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 |
-13.9; -14; -14.3; -12.6; -14; -14.2 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 |
89.8; 86.7; 82.5; 74.2; 88; 80.5 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female participants ≥ 18 years of age with hypertension 1-2 grade.
- Participants with:
- newly diagnosed arterial HTN or
- inadequately controlled previously prescribed monotherapy with Renin-Angiotensin-Aldosterone System (RAAS) blocker or
- inadequately controlled previously prescribed combination therapy with RAAS blocker + diuretic or RAAS blocker + calcium antagonist.
- The physician decides to prescribe Edarbi®
- as monotherapy or
- as a part of combination therapy including diuretics or calcium antagonists;
- Overweight or obesity of any degree (body mass index> 25 kg/m^2);
- Is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.
Exclusion Criteria
- Confirmed secondary HTN;
- Contraindications for Edarbi® of respective approved local summary of product characteristics (SmPC) of Edarbi®;
- Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study.
- Is an employee or family member of the investigator or study site personnel.
- Is currently participating in a clinical trial. Participation in non-interventional registries is permitted.
Data sourced from ClinicalTrials.gov (NCT02756819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.