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HypertensionNCT00803660

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

An observational study of Hypertension and Type 2 Diabetes, run by AstraZeneca at 19 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Type 2 Diabetes
How many people
1,060 participants
Where
19 sitesVietnam
Study dates
Nov 2008to May 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Vietnam19 sites

  • Research Site

    Bạc Liêu, Bac Lieu

  • Research Site

    Bien Hoa, Dong Nai

  • Research Site

    Buon Me Thuoc, Dak Lak

  • Research Site

    Ca Mau, Ca Mau

  • Research Site

    Can Tho, Can Tho City

  • Research Site

    Châu Đốc, An Giang

  • Research Site

    Da Nang, Da Nang

  • Research Site

    Dong Thap, Dong Thap

  • Research Site

    Haiphong

  • Research Site

    Hanoi, Hanoi

  • Research Site

    Ho Chi Minh City

  • Research Site

    Huế, Thua Thien

  • Research Site

    Kiến Giang, Kien Giang

  • Research Site

    Nam Định, Nam Dinh

  • Research Site

    Nha Trang, Khanh Hoa

  • Research Site

    Qui Nhon, Binh Dinh

  • Research Site

    Thái Bình, Thai Binh

  • Research Site

    Thống Nhất, Dong Nai

  • Research Site

    Tiền Giang, Tien Giang

Other trials in Vietnam

About this study

Official title: 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 .

Keywords
hypertension, BP, diabetes, anti-hypertensive treatment, ACE-I, ARB
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

  1. The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups

  2. The number and percentage of patients achieving HbA1c=<7%

  3. The number and percentage of patients achieving the FPG<110 mg%

  4. 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...)

  5. The number and percentage of patients with positive proteinuria by treatment groups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Cross-sectional
Enrolment
1,060 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00803660
Sponsor's protocol ID
NIS-CVN-DUM-2008/1
Status last verified
Jul 2009
First submitted
3 Dec 2008
Last updated
9 Jul 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Type 2 Diabetes, run by AstraZeneca at 19 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of patients achieving the BP<130/80 mmHg. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00803660.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2009.

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