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Observational Study to Investigate Resistant Hypertension Prevalence in Korean General Hospitals (Teveten_RH)

This study is currently recruiting participants.
Verified March 2013 by Handok Pharmaceuticals Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01753206
First received: December 17, 2012
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

Study Objectives The study is to identify prevalence, demography and clinical characteristics of patients with resistant hypertension among hypertensive patients who have been treated in general hospitals in Korea from Jan 2012 to Jun 2012.

  • Diagnosis of resistant hypertension: In case of clinic blood pressure exceeding the boundary of systolic blood pressure at 140mmHg and diastolic blood pressure at 90mmHg (hereinafter refer to as 140/90mmHg) (130/80mmHg for patients with diabetes mellitus or chronic renal disease) despite triple antihypertensive therapy at optimal dose may be diagnosed as resistant hypertension. Antihypertensive medications used include diuretics. Resistant hypertension may also be diagnosed when clinic blood pressure has reached the target value but quadruple or more of antihypertensives are used.
  • Diagnosis of controlled hypertension: Patients whose clinic blood pressure equals to 140/90mmHg (130/80mmHg for patients with diabetes mellitus or chronic renal disease) or less with the administration of antihypertensives at optimal dose may be diagnosed as controlled hypertension.

Condition
Hypertension

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Observational Study to Investigate Resistant Hypertension Prevalence Among the Hypertensive Patients Who Have Been Treated in Korean General Hospitals

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Handok Pharmaceuticals Co., Ltd.:

Primary Outcome Measures:
  • Prevalence of resistant hypertension [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Prevalence of resistant hypertension will be estimated, and its 95% confidence interval will be calculated. In addition, proportion of controlled hypertensive patients and its 95% confidence interval will be calculated.


Secondary Outcome Measures:
  • Analysis of correlation in patients with resistant hypertension and patients with controlled hypertension who received triple antihypertensive therapy in terms of demography, clinical characteristics and other factors [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Clinical characteristics in subjects diagnosed of resistant hypertension and those diagnosed of controlled hypertension will be described in summary.


Estimated Enrollment: 1800
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Primary Objective:

Prevalence in patients with resistant hypertension among hypertensive patients who have been treated in Korean general hospitals

Secondary Objectives:

Analysis of correlation in patients with resistant hypertension and patients with controlled hypertension who received triple antihypertensive therapy in terms of demography, clinical characteristics and other factors

  1. Demographic data (age, sex, and body mass index)

  2. Clinical characteristics

    • Vital signs
    • Lifestyles (history of drinking, smoking, and exercise)
    • Family history (hypertension, diabetes mellitus, dyslipidemia, cardiovascular disease, renal/adrenal disease, cerebrovascular disease, and respiratory disease)
    • Concurrent diseases (diabetes mellitus, dyslipidemia, cardiovascular disease, renal/adrenal disease, cerebrovascular disease, respiratory disease, and others)
    • History of antihypertensive therapy (past and present)
    • Medication compliance of antihypertensives
    • Concomitant medications
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

General hospitals

Criteria

Inclusion Criteria:

  1. Patients diagnosed of hypertension and in 20 years of age or older at the time of participating the study
  2. Patients visiting the medical institution during the period of 01 2012 ~ 06 2012 and who have received triple or more of antihypertensive therapy including diuretics (all different classes one another) at the time of the investigation.
  3. Patients who signed the informed consent form for data use before undergoing the study procedures.
  4. Patients who have capability and are willing to understand and fill in the questionnaire used in this study or who have a representative to fill in the questionnaire in case of lacking the capability.

Exclusion Criteria:

1. Patients who fail to meet the inclusion criteria.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753206

Contacts
Contact: Dongjin Shin 82-2-527-5383 dongjin.shin@handok.com

Locations
Korea, Republic of
Handok Pharmaceuticals Co.,Ltd Recruiting
Seoul, Korea, Republic of, 135-755
Contact: Dongjin Shin     82-2-527-5383     dongjin.shin@handok.ocm    
Principal Investigator: Dong-Ju Choi, MD            
Sponsors and Collaborators
Handok Pharmaceuticals Co., Ltd.
Investigators
Principal Investigator: Dong-Ju Choi, MD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Handok Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT01753206     History of Changes
Other Study ID Numbers: HD_EPR_OS2012
Study First Received: December 17, 2012
Last Updated: March 13, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013