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Retrospective Survey for Patients With Hypertension and Diabetes Mellitus (CRYSTAL)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681278
First received: May 19, 2008
Last updated: December 1, 2010
Last verified: December 2010
History of Changes
  Purpose

This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of hypertension patients having Type 2 Diabetes mellitus, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.


Condition
Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective, Multi Centre, Non-interventional, Observational Study to Investigate Treatment Pattern of Blood Pressure in the Type II Diabetes Mellitus Patients With Hypertension.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Attainment rate to the target blood pressure. [ Time Frame: After collecting all Patient Record Form. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dropout rate will be estimated during the follow-up period after the hypertension treatment. Attainment to the target blood pressure will be investigated according to concomitant diseases. [ Time Frame: After collecting all Patient Record Form. ] [ Designated as safety issue: No ]
  • Change in DBP/SBP value during the follow-up period will be addressed. Change in the DBP/SBP value will be investigated according to the risk factors and concurrent disease. [ Time Frame: After collecting all Patient Record Form. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Hypertension patients with Type II Diabetes mellitus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with type II Diabetes mellitus, receiving hypertension medication during at least 1 year.

Criteria

Inclusion Criteria:

  • Outpatient Type II DM patients receiving hypertension medication in 2006
  • Patient with Type II DM receiving hypertension medication during at least 1 year.

Exclusion Criteria:

  • Secondary hypertension patients
  • Patients not receiving hypertension medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681278

Locations
Korea, Republic of
Research Site
Bucheon, Gyeonggi, Korea, Republic of
Research Site
Goyang, Gyeonggi, Korea, Republic of
Research Site
Guri, Gyeonggi, Korea, Republic of
Research Site
Sungnam, Gyeonggi, Korea, Republic of
Research Site
Jeonju, Keollabuk, Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Deagu, Korea, Republic of
Research Site
Deajeon, Korea, Republic of
Research Site
Incheon, Korea, Republic of
Research Site
Kwangju, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Suwon, Korea, Republic of
Research Site
Wonju, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joon Woo Bahn Astrazenca Korea medical dept,.
  More Information

No publications provided

Responsible Party: Joon Woo Bahn, AstraZeneca
ClinicalTrials.gov Identifier: NCT00681278     History of Changes
Other Study ID Numbers: NIS-CKR-DUM-2008/2
Study First Received: May 19, 2008
Last Updated: December 1, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Hypertension
Type II DM
JNC7
2007 ESH-ESC guidelines
survey

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013