NCT00803660

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,060

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

First QC Date

December 3, 2008

Last Update Submit

July 8, 2009

Conditions

HypertensionType 2 Diabetes

Keywords

hypertensionBPdiabetesanti-hypertensive treatmentACE-IARB

Outcome Measures

Primary Outcomes (2)

  • The number of patients achieving the BP<130/80 mmHg

  • The percentage of patients achieving the BP<130/80 mmHg

Secondary Outcomes (5)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Châu Đốc, An Giang, Vietnam

Location

Research Site

Bạc Liêu, Bac Lieu, Vietnam

Location

Research Site

Qui Nhon, Binh Dinh, Vietnam

Location

Research Site

Cà Mau, Ca Mau, Vietnam

Location

Research Site

Can Tho, Can Tho City, Vietnam

Location

Research Site

Da Nang, Da Nang, Vietnam

Location

Research Site

Buon Me Thuoc, Dak Lak, Vietnam

Location

Research Site

Biên Hòa, Dong Nai, Vietnam

Location

Research Site

Thống Nhất, Dong Nai, Vietnam

Location

Research Site

Dong Thap, Dong Thap, Vietnam

Location

Research Site

Hanoi, Hanoi, Vietnam

Location

Research Site

Nha Trang, Khanh Hoa, Vietnam

Location

Research Site

Kiến Giang, Kien Giang, Vietnam

Location

Research Site

Nam Định, Nam Dinh, Vietnam

Location

Research Site

Thái Bình, Thai Binh, Vietnam

Location

Research Site

Huế, Thua Thien, Vietnam

Location

Research Site

Tiền Giang, Tien Giang, Vietnam

Location

Research Site

Haiphong, Vietnam

Location

Research Site

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 5, 2008

Study Start

November 1, 2008

Study Completion

May 1, 2009

Last Updated

July 9, 2009

Record last verified: 2009-07

Locations

VN(19)