Essential HypertensionSORTNCT01295021
The Prevalence of Sympathetic Overactivity in Primary Hypertensive Patients.
An observational study of Essential Hypertension, run by AstraZeneca at 97 sites in India.
Trial summary
The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients with newly diagnosed essential hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension
- How many people
- 1,514 participants
- Where
- 97 sitesIndia
- Study dates
- Feb 2011to Feb 2012
- 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: Primary hypertensive patients
Who may be able to join
- 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
Who cannot join
- History of coronary artery disease
- History of diabetes
Trial locations and contacts
97 sites in 1 country.
97 sites in 1 country
India97 sites
Research Site
Agartala
Research Site
Agra
Research Site
Ahmedabad
Research Site
Aligarh
Research Site
Ambattur
Research Site
Amritsar
Research Site
Bangalore
Research Site
Barelly
Research Site
Baroda
Research Site
Batanagar
Research Site
Beed
Research Site
Belagavi
Research Site
Bhagal
Research Site
Bhongi
Research Site
Bhopal
Research Site
Bhuj
Research Site
Burdwan
Research Site
Chandigarh
Research Site
Chennai
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Chhatrapati Sambhajinagar
Research Site
Chomv
Research Site
Coimbatore
Research Site
Davangere
Research Site
Delhi
Research Site
Dhule
Research Site
Dombivali
Research Site
Ellisbridge
Research Site
Fariadad
Research Site
Faridabad
Research Site
Gandhinagar
Research Site
Ghatkopar East
Research Site
Ghaziabad
Research Site
Guntur
Research Site
Gūrgaon
Research Site
Gwalior
Research Site
Hanamkonda
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Hubli
Research Site
Hugli
Research Site
Hyderabad
Research Site
Indore
Research Site
Jabalpur
Research Site
Jaipur
Research Site
Jalandhar
Research Site
Jalgoon
Research Site
Kākināda
Research Site
Kalaburagi
Research Site
Kanpur
Research Site
Karad
Research Site
Karīmnagar
Research Site
Kolhāpur
Research Site
Kolkata
Research Site
Kulhapu
Research Site
Kumta
Research Site
Lucknow
Research Site
Ludhiana
Research Site
Madhyamgram
Research Site
Madurai
Research Site
Miroj
Research Site
Mohali
Research Site
Mozda
Research Site
Mrit Home
Research Site
Mulund East
Research Site
Mumbai
Research Site
Murshidābād
Research Site
Nadiād
Research Site
Nagpur
Research Site
Nashik
Research Site
Naugloi
Research Site
Navi Mumbai
Research Site
Nesul
Research Site
New Delhi
Research Site
New Panvel
Research Site
Newdelhi
Research Site
Nipāni
Research Site
Op Inchapur
Research Site
Pālanpur
Research Site
Panvel
Research Site
Parganas (Wb)
Research Site
Pune
Research Site
Raipur
Research Site
Rajkot
Research Site
Rajpur Sonarpur
Research Site
Sahibabad,Gzb
Research Site
Secenderabad
Research Site
Shakarpur
Research Site
Shimoga
Research Site
Sowcarpet
Research Site
Surat
Research Site
Thane
Research Site
Tirupati
Research Site
Ulhasnagar
Research Site
Vadodara
Research Site
Vijayawada
Research Site
Virār
Research Site
Visakhapatnam
Research Site
Vizag
Research Site
Warangal
About this study
Official title: 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.
Read the detailed description
MC MD
- Conditions
- Essential Hypertension
- Keywords
- The prevalence of sympathetic overactivity in hypertensive patients.
- Medical subject headings
- Essential Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SO in newly diagnosed hypertensive patients
Measured: 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.
Secondary outcomes (3)
Association of SO and heart rate.
Measured: Visits 1-3
Subjective symptoms noticed by the doctor.
Measured: 1st visit
To record the drugs used in the treatment of patients diagnosed with hypertension.
Measured: Visits 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,514 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr T.N.C. Padmanabhan, Principal investigator, Dr. Padmanabhan Heart Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295021
- Sponsor's protocol ID
- NIS-CIN-DUM-2010/2
- Acronym
- SORT
- Status last verified
- Jun 2013
- First submitted
- 3 Feb 2011
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non Interventional, Cross Sectional, Study on the Prevalence of Sympathetic Overactivity in Hypertensive Patients.
- ClinicalTrials.gov ID
- NCT01295021
- Acronym / sponsor ID
- SORT / NIS-CIN-DUM-2010/2
- Conditions
- Essential Hypertension
- Keywords
- The prevalence of sympathetic overactivity in hypertensive patients.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,514 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this NIS is to assess the prevalence of sympathetic overactivity in patients with newly diagnosed essential hypertension.
Detailed description
MC MD
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary hypertensive patients
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- History of coronary artery disease
- History of diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Association of SO and heart rate.
Time frame: Visits 1-3
Subjective symptoms noticed by the doctor.
Time frame: 1st visit
To record the drugs used in the treatment of patients diagnosed with hypertension.
Time frame: Visits 1-3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
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A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr T.N.C. Padmanabhan principal investigator
Dr. Padmanabhan Heart Clinic
97 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by AstraZeneca at 97 sites in India.
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 2 inclusion and 2 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 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in India. 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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2013.