Trial record 1 of 1 for:
NCT02756819
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
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02756819 |
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Recruitment Status :
Completed
First Posted : April 29, 2016
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Brief 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..
| Condition or disease | Intervention/treatment |
|---|---|
| Hypertension | Drug: Azilsartan Medoxomil |
The drug being tested in this study is called azilsartan medoxomil (Edarbi®). Azilsartan medoxomil is being tested to treat people who have hypertension. This study looks at the clinic systolic and diastolic blood pressure (SBP, DBP) in obese participants who were prescribed azilsartan medoxomil by physicians.
The study enrolled 1945 patients. All participants were asked to take azilsartan medoxomil as prescribed by their physician according to local SmPC.
This multi-center trial was conducted in the Russian Federation and the Republic of Kazakhstan. The overall duration of study for observation was approximately 6 months. Participants made multiple visits to the clinics as assigned by each physician according to their routine practice, in every 3 months.
| Study Type : | Observational |
| Actual Enrollment : | 1945 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | International Multicentre, Observational, Non-Interventional Prospective Study of Azilsartan Medoxomil in Patients With Arterial Hypertension Who Are Overweight or Obese in the Russian Federation and The Republic of Kazakhstan |
| Actual Study Start Date : | July 18, 2016 |
| Actual Primary Completion Date : | May 8, 2018 |
| Actual Study Completion Date : | May 8, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Hypertension
Drug Information available for:
Azilsartan medoxomil
| Group/Cohort | Intervention/treatment |
|---|---|
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Azilsartan Medoxomil
Overweight or obese participants with hypertension who received azilsartan medoxomil tablets, orally, as prescribed by physician according to local summary of product characteristics (SmPC) were observed for approximately 6 months.
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Drug: Azilsartan Medoxomil
Azilsartan medoxomil tablets
Other Name: Edarbi® |
Primary Outcome Measures :
- Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 [ Time Frame: Baseline and Month 6 ]The change in clinic sitting SBP measured at Month 6 relative to baseline.
Secondary Outcome Measures :
- Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6 [ Time Frame: Baseline and Month 6 ]The change in clinic sitting DBP measured at Month 6 relative to baseline.
- Percentage of Participants With Response at Month 6 [ Time Frame: Month 6 ]Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg.
- Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg [ Time Frame: Month 6 ]
- Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6 [ Time Frame: Baseline and Month 6 ]The change in clinic sitting SBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate [BMI] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus (DM) nor metabolic syndrome.
- Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6 [ Time Frame: Baseline and Month 6 ]The change in clinic sitting DBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate [BMI] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus nor metabolic syndrome.
- Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6 [ Time Frame: Month 6 ]Target BP was SBP<140 mm Hg and DBP<90 mm Hg. Subgroups included BMI, overweight, Obesity I (BMI 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance (Yes/No), metabolic syndrome (Yes/No) and diabetes mellitus (Yes/No).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Overweight or obese participants with Hypertension (HTN) grade 1-2 were observed.
Criteria
Inclusion Criteria:
- Male and female participants ≥ 18 years of age with hypertension 1-2 grade.
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756819
Locations
Show 66 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Medical Director Clinical Science | Takeda |
Study Documents (Full-Text)
Documents provided by Takeda:
Documents provided by Takeda:
Statistical Analysis Plan [PDF] February 20, 2019
Study Protocol [PDF] January 9, 2019
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT02756819 |
| Other Study ID Numbers: |
Azilsmedox-5008 MACS-2014-100663 ( Other Identifier: Takeda ) |
| First Posted: | April 29, 2016 Key Record Dates |
| Results First Posted: | November 20, 2019 |
| Last Update Posted: | November 20, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takeda:
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Drug Therapy |
Additional relevant MeSH terms:
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Hypertension Overweight Vascular Diseases Cardiovascular Diseases Body Weight |
Azilsartan medoxomil Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |