- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295021
The Prevalence of Sympathetic Overactivity in Primary Hypertensive Patients. (SORT)
June 7, 2013 updated by: AstraZeneca
A Non Interventional, Cross Sectional, Study on the Prevalence of Sympathetic Overactivity in Hypertensive Patients.
The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients with newly diagnosed essential hypertension.
Study Overview
Status
Completed
Conditions
Detailed Description
MC MD
Study Type
Observational
Enrollment (Actual)
1514
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Agartala, India
- Research Site
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Agra, India
- Research Site
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Ahmedabad, India
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Aligarh, India
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Ambattur, India
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Amritsar, India
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Aurangabad, India
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Bangalore, India
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Barelly, India
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Baroda, India
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Batanagar, India
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Beed, India
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Belgaum, India
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Bhagal, India
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Bhongi, India
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Bhopal, India
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Bhuj, India
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Burdwan, India
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Chandigarh, India
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Chennai, India
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Chomv, India
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Coimbatore, India
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Davangere, India
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Delhi, India
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Dhule, India
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Dombivli, India
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Ellisbridge, India
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Fariadad, India
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Faridabad, India
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Gandhinagar, India
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Ghatkopar East, India
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Ghaziabad, India
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Gulbarga, India
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Guntur, India
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Gurgaon, India
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Gwalior, India
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Hanamkonda, India
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Hooghly, India
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Hubli, India
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Hyd, India
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Hyderabad, India
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Indore, India
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Jabalpur, India
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Jaipur, India
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Jalandhar, India
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Jalgoon, India
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Kakinada, India
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Kanpur, India
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Karad, India
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Karimnagar, India
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Kolhapur, India
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Kolkata, India
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Kolkata-, India
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Kulhapu, India
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Kumta, India
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Lucknow, India
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Ludhiana, India
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Madhyamgram, India
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Madurai, India
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Miroj, India
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Mohali, India
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Mozda, India
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Mrit Home, India
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Mulund, India
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Mumbai, India
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Murshidabad, India
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Nadiad, India
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Nagpur, India
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Nasik, India
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Naugloi, India
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Navi Mumbai, India
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Nesul, India
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New Delhi, India
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New Panvel, India
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Newdelhi, India
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Nipani, India
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Op Inchapur, India
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Palanpur, India
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Panvel., India
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Parganas (Wb), India
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Pune, India
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Raipur, India
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Rajkot, India
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Sahibabad,Gzb, India
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Secenderabad, India
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Shakar Pur, India
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Shimoga, India
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Sonarpur, India
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Sowcarpet, India
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Surat, India
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Thane, India
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Tirupati, India
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Ulhasnagar, India
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Vadodara, India
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Vijayawada, India
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Virar, India
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Visakhapatnam, India
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Vizag, India
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Warangal, India
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary hypertensive patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Association of SO and heart rate.
Time Frame: Visits 1-3
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Visits 1-3
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Subjective symptoms noticed by the doctor.
Time Frame: 1st visit
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1st visit
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To record the drugs used in the treatment of patients diagnosed with hypertension.
Time Frame: Visits 1-3
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Visits 1-3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr T.N.C. Padmanabhan, Dr. Padmanabhan Heart Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
February 3, 2011
First Submitted That Met QC Criteria
February 10, 2011
First Posted (Estimate)
February 14, 2011
Study Record Updates
Last Update Posted (Estimate)
June 10, 2013
Last Update Submitted That Met QC Criteria
June 7, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-CIN-DUM-2010/2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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