Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 1 for:    NCT02756819
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02756819
First received: April 27, 2016
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
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 Intervention
Hypertension
Drug: Azilsartan Medoxomil

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change from Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6 [ Time Frame: Baseline and Month 6 (Visit 4) ]
    The change in systolic blood pressure measured at visit 4 (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 (Visit 4) ]
    The change in systolic blood pressure measured at visit 4 (month 6) relative to baseline.

  • Percentage of Participants With Response [ Time Frame: Baseline and Month 6 (Visit 4) ]
    Response is defined as decrease of SBP ≥20 mm Hg or decrease of DBP ≥10 mm Hg.

  • Percentage of Participants who Achieve Target Blood Pressure (BP) <140 mm Hg [ Time Frame: Baseline and Month 6 (Visit 4) ]
    Target BP is defined as SBP <140 mm Hg and DBP <90 mm Hg.

  • Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants [ Time Frame: Baseline and Month 6 (Visit 4) ]
    Subgroups include participants who are overweight (body mass index [BMI] =25 to 30 kg/m^2), obese (BMI >30 kg/m^2), have impaired glucose tolerance, metabolic syndrome and diabetes mellitus.

  • Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants [ Time Frame: Baseline and Month 6 (Visit 4) ]
    Subgroups include participants who are overweight (body mass index [BMI] =25 to 30 kg/m^2), obese (BMI >30 kg/m^2), have impaired glucose tolerance, metabolic syndrome and diabetes mellitus.

  • Percentage of Participants Who Achieve Target Blood Pressure (BP) in Subgroups of Participants [ Time Frame: Baseline and Month 6 (Visit 4) ]
    Target BP is defined as SBP <140 mm Hg and DBP <90 mm Hg. Subgroups include participants who are overweight (body mass index [BMI] =25 to 30 kg/m^2), obese (BMI >30 kg/m^2), have impaired glucose tolerance, metabolic syndrome and diabetes mellitus.


Estimated Enrollment: 1916
Actual Study Start Date: June 8, 2016
Estimated Study Completion Date: March 1, 2018
Estimated Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Azilsartan Medoxomil
Overweight or obese participants with hypertension who will receive azilsartan medoxomil tablets,orally, as prescribed by physician according to local summary of product characteristics (SmPC) will be observed for approximately 6 months.
Drug: Azilsartan Medoxomil
Azilsartan medoxomil tablets
Other Name: Edarbi

Detailed Description:

The drug being tested in this study is called azilsartan medoxomil. Azilsartan medoxomil is being tested to treat people who have hypertension. This study will look at the clinic systolic and diastolic blood pressure (SBP, DBP) in obese participants who will be prescribed with azilsartan medoxomil by physician.

The study will enroll approximately 1916 patients. All participants will be asked to take azilsartan medoxomil as prescribed by their physician according to local SmPC.

This multi-center trial will be conducted in the Russian Federation and the Republic of Kazakhstan. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Overweight or obese participants with Hypertension grade 1-2 will be observed.
Criteria

Inclusion Criteria:

  1. Male and female participants ≥ 18 years of age with hypertension (HTN) 1-2 grade.
  2. 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.
  3. The physician decides to prescribe Edarbi

    • as monotherapy or
    • as a part of combination therapy including diuretics or calcium antagonists;
  4. Overweight or obesity of any degree (body mass index> 25 kg/m^2);
  5. 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:

  1. Confirmed secondary HTN;
  2. Contraindications for Edarbi of respective approved local summary of product characteristics (SmPC) of Edarbi;
  3. Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study.
  4. Is an employee or family member of the investigator or study site personnel.
  5. Is currently participating in a clinical trial. Participation in non-interventional registries is permitted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02756819

Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

Locations
Russian Federation
Recruiting
Orekhovo-Zuevo, Russian Federation
Recruiting
Penza, Russian Federation
Recruiting
Saint-Petersburg, Russian Federation
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02756819     History of Changes
Other Study ID Numbers: Azilsmedox-5008
MACS-2014-100663 ( Other Identifier: Takeda )
Study First Received: April 27, 2016
Last Updated: April 6, 2017

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Hypertension
Overweight
Vascular Diseases
Cardiovascular Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 28, 2017