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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803660
• Other study ID #: NIS-CVN-DUM-2008/1
• Status: Completed
• Phase: N/A
• First received: December 3, 2008
• Last updated: July 8, 2009
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: July 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1060
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes

Locations

Country	Name	City	State
Vietnam	Research Site	An Giang
Vietnam	Research Site	Bac Lieu
Vietnam	Research Site	Bien Hoa	Dong Nai
Vietnam	Research Site	Buon Me Thuoc	Dak Lak
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	Hue	Thua Thien
Vietnam	Research Site	Kien Giang
Vietnam	Research Site	Nam Dinh
Vietnam	Research Site	Nha Trang	Khanh Hoa
Vietnam	Research Site	Qui Nhon	Binh Dinh
Vietnam	Research Site	Thai Binh
Vietnam	Research Site	Thong Nhat	Dong Nai
Vietnam	Research Site	Tien Giang

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients achieving the BP<130/80 mmHg			No
Primary	The percentage of patients achieving the BP<130/80 mmHg			No
Secondary	The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups			No
Secondary	The number and percentage of patients achieving HbA1c=<7%			No
Secondary	The number and percentage of patients achieving the FPG<110 mg%			No
Secondary	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...)			No
Secondary	The number and percentage of patients with positive proteinuria by treatment groups			No