Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes

July 8, 2009 updated by: AstraZeneca

In Practice Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes.

Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive treatment. Data collection for each patient will take place at one visit. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP<130/80 mmHg. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a therapeutic glycemic response defined as HbA1c=<7%. To observe the proportion of patients achieving fasting plasma glucose<110 mg%. To identify factors for not achieving BP<130/80 mmHg. To describe percentage of patients with positive proteinuria (including microalbuminuria) by treatment groups .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1060

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • An Giang, Vietnam
        • Research Site
      • Bac Lieu, Vietnam
        • Research Site
      • Ca Mau, Vietnam
        • Research Site
      • Can Tho, Vietnam
        • Research Site
      • Da Nang, Vietnam
        • Research Site
      • Dong Thap, Vietnam
        • Research Site
      • Hai Phong, Vietnam
        • Research Site
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • Research Site
      • Kien Giang, Vietnam
        • Research Site
      • Nam Dinh, Vietnam
        • Research Site
      • Thai Binh, Vietnam
        • Research Site
      • Tien Giang, Vietnam
        • Research Site
    • Binh Dinh
      • Qui Nhon, Binh Dinh, Vietnam
        • Research Site
    • Dak Lak
      • Buon Me Thuoc, Dak Lak, Vietnam
        • Research Site
    • Dong Nai
      • Bien Hoa, Dong Nai, Vietnam
        • Research Site
      • Thong Nhat, Dong Nai, Vietnam
        • Research Site
    • Khanh Hoa
      • Nha Trang, Khanh Hoa, Vietnam
        • Research Site
    • Thua Thien
      • Hue, Thua Thien, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

type 2 diabetic patients who are currently using antihypertensive treatment for at least 3 months, with same regimen for a minimum of 4 weeks prior to the survey

Description

Inclusion Criteria:

  • Provision of written informed consent
  • Patient was diagnosed with type 2 diabetes
  • Patient is on antihypertensive treatments for at least 3 months, with the same regimen for a minimum of 4 weeks prior to survey

Exclusion Criteria:

  • Patients are critically ill, had mental health problems or difficulty in communication
  • Patients who are unwilling or unable to provide informed consent
  • Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The number of patients achieving the BP<130/80 mmHg
The percentage of patients achieving the BP<130/80 mmHg

Secondary Outcome Measures

Outcome Measure
The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups
The number and percentage of patients achieving HbA1c=<7%
The number and percentage of patients achieving the FPG<110 mg%
The association between unachievement of BP<130/80 mmHg and other factors (age, gender, CV risk factors, CV and diabetes history, duration of type of treatment...)
The number and percentage of patients with positive proteinuria by treatment groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Dang Van Phuoc, PhD., University of Medicine and Pharmacy of HCMC
  • Principal Investigator: Pham Nguyen Vinh, PhD., Tam Duc Heart Hospital
  • Principal Investigator: Pham Gia Khai, PhD., Vietnam Heart Association
  • Principal Investigator: Nguyen Thy Khue, PhD, Endocrinology and Diabetes Association of HCMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

July 9, 2009

Last Update Submitted That Met QC Criteria

July 8, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CVN-DUM-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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