Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00803660

Purpose

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 .

Condition
Hypertension Type 2 Diabetes

Study Type:	Observational
Study Design:	Time Perspective: Cross-Sectional
Official Title:	In Practice Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Blood Pressure Medicines Diabetes Diabetes Type 2 High Blood Pressure

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The number of patients achieving the BP<130/80 mmHg [ Designated as safety issue: No ]
The percentage of patients achieving the BP<130/80 mmHg [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups [ Designated as safety issue: No ]
The number and percentage of patients achieving HbA1c=<7% [ Designated as safety issue: No ]
The number and percentage of patients achieving the FPG<110 mg% [ Designated as safety issue: No ]
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...) [ Designated as safety issue: No ]
The number and percentage of patients with positive proteinuria by treatment groups [ Designated as safety issue: No ]

Estimated Enrollment:	1060
Study Start Date:	November 2008
Study Completion Date:	May 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803660

Locations

Vietnam
Research Site
Qui Nhon, Binh Dinh, Vietnam
Research Site
Buon Me Thuoc, Dak Lak, Vietnam
Research Site
Bien Hoa, Dong Nai, Vietnam
Research Site
Thong Nhat, Dong Nai, Vietnam
Research Site
Nha Trang, Khanh Hoa, Vietnam
Research Site
Hue, Thua Thien, Vietnam
Research Site
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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Vo Viet Tuan, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00803660 History of Changes
Other Study ID Numbers:	NIS-CVN-DUM-2008/1
Study First Received:	December 3, 2008
Last Updated:	July 8, 2009
Health Authority:	Vietnam: Ministry of Health

Keywords provided by AstraZeneca:

hypertension
BP
diabetes

anti-hypertensive treatment
ACE-I
ARB

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012