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The Prevalence of Sympathetic Overactivity in Primary Hypertensive Patients. (SORT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01295021
First received: February 3, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients with newly diagnosed essential hypertension.


Condition
Essential Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Non Interventional, Cross Sectional, Study on the Prevalence of Sympathetic Overactivity in Hypertensive Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Prevalence of SO in newly diagnosed hypertensive patients [ Time Frame: Visit 1-3: heart rate & Blood pressure, treatment presribed by physician. The interval between visit 1 and visit 2 is upto 4 weeks and interval between visit 2 & visit 3 is upto 4 weeks depending on Investigators discretion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of SO and heart rate. [ Time Frame: Visits 1-3 ] [ Designated as safety issue: No ]
  • Subjective symptoms noticed by the doctor. [ Time Frame: 1st visit ] [ Designated as safety issue: No ]
  • To record the drugs used in the treatment of patients diagnosed with hypertension. [ Time Frame: Visits 1-3 ] [ Designated as safety issue: No ]

Enrollment: 5400
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Detailed Description:

MC MD

  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

Primary hypertensive patients

Criteria

Inclusion Criteria:

  • Newly diagnosed essential hypertension patients will be eligible for the study.
  • Average of two or more systolic BP readings ≥ 140mmHg or diastolic BP readings ≥ 90mmHg

Exclusion Criteria:

  • History of coronary artery disease
  • History of diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295021

  Show 99 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dr T.N.C. Padmanabhan Dr. Padmanabhan Heart Clinic
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01295021     History of Changes
Other Study ID Numbers: NIS-CIN-DUM-2010/2
Study First Received: February 3, 2011
Last Updated: February 20, 2013
Health Authority: India: Drugs Controller General of India

Keywords provided by AstraZeneca:
The prevalence of sympathetic overactivity in hypertensive patients.

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013