Stroke Clinical Trial
Official title:
Stroke Estimation (According to Framingham Profile ParameterS) in Patients Under medicAtion Due to Essential Hypertension. (NASA)
Verified date | August 2014 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ministry of Health and Welfare |
Study type | Observational |
The primary objective of the study is to evaluate the proportion of hypertensive patients
who achieve regulation of their blood pressure (BP) levels according to the European Society
of Cardiology / European School of Haematology (ESC/ESH) Guidelines, after treatment with
eprosartan for 6 months under standard medical practice conditions. The absolute change in
Systolic blood pressure from baseline will also be calculated.
This study also aims in the evaluation of Framingham stroke risk profile score of patients
treated with eprosartan under standard clinical practice conditions during the observation
period. Besides the primary and the secondary objective of the study, the assessment of the
percentage of patients who experienced Adverse Events (AEs), Serious Adverse Events (SAEs),
Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) (overall and per
observed event) and the percentage of patients who discontinued treatment prematurely before
the advent of the 6-month observation period due to toxicity to the study medication
constitutes another important objective that is related to the safety of the treatment.
Status | Completed |
Enrollment | 533 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients (age greater or equal to 18 years) 2. Hypertensive patients, with a sitting Systolic Blood Pressure above 140 mmHg or 130 mmHg in diabetics and high/very high risk patients, according to ESC/ESH Guidelines 3. Patients being prescribed eprosartan under the terms and conditions of the local label and administered according to standard medical practice 4. Patients with at least one of the following conditions: - Newly diagnosed hypertension, - Inability to tolerate other antihypertensive medications, or - Lack of response to current antihypertensive medication(s) Exclusion Criteria: 1. Any contraindication to eprosartan or the excipients (according to the local label) |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Site Reference ID/Investigator# 62499 | Agrinio | |
Greece | Site Reference ID/Investigator# 62500 | Agrinio | |
Greece | Site Reference ID/Investigator# 62577 | Alimos | |
Greece | Site Reference ID/Investigator# 62384 | Athens | |
Greece | Site Reference ID/Investigator# 62386 | Athens | |
Greece | Site Reference ID/Investigator# 62389 | Athens | |
Greece | Site Reference ID/Investigator# 62398 | Athens | |
Greece | Site Reference ID/Investigator# 62391 | Chalandri | |
Greece | Site Reference ID/Investigator# 62392 | Chalandri | |
Greece | Site Reference ID/Investigator# 62395 | Chalandri | |
Greece | Site Reference ID/Investigator# 62629 | Chalkida | |
Greece | Site Reference ID/Investigator# 62633 | Chalkida | |
Greece | Site Reference ID/Investigator# 62507 | Chania | |
Greece | Site Reference ID/Investigator# 62508 | Chania | |
Greece | Site Reference ID/Investigator# 62511 | Chania | |
Greece | Site Reference ID/Investigator# 62588 | Chania | |
Greece | Site Reference ID/Investigator# 62484 | Drama | |
Greece | Site Reference ID/Investigator# 62518 | Eleftherio, Thessaloniki | |
Greece | Site Reference ID/Investigator# 62512 | Euosmos, Thessaloniki | |
Greece | Site Reference ID/Investigator# 62390 | Galatsi | |
Greece | Site Reference ID/Investigator# 62584 | Glyfada | |
Greece | Site Reference ID/Investigator# 62586 | Glyfada | |
Greece | Site Reference ID/Investigator# 62505 | Heraklion | |
Greece | Site Reference ID/Investigator# 62587 | Heraklion | |
Greece | Site Reference ID/Investigator# 62589 | Heraklion | |
Greece | Site Reference ID/Investigator# 62591 | Heraklion | |
Greece | Site Reference ID/Investigator# 62593 | Heraklion | |
Greece | Site Reference ID/Investigator# 62493 | Ioannina | |
Greece | Site Reference ID/Investigator# 62497 | Ioannina | |
Greece | Site Reference ID/Investigator# 62503 | Ioannina | |
Greece | Site Reference ID/Investigator# 62487 | Kalamata | |
Greece | Site Reference ID/Investigator# 62580 | Kallithea | |
Greece | Site Reference ID/Investigator# 62644 | Kavala | |
Greece | Site Reference ID/Investigator# 62645 | Kavala | |
Greece | Site Reference ID/Investigator# 62483 | Komotini | |
Greece | Site Reference ID/Investigator# 62642 | Komotini | |
Greece | Site Reference ID/Investigator# 62575 | Korydallos | |
Greece | Site Reference ID/Investigator# 62631 | Lamia | |
Greece | Site Reference ID/Investigator# 62635 | Lamia | |
Greece | Site Reference ID/Investigator# 62626 | Larisa | |
Greece | Site Reference ID/Investigator# 62628 | Larisa | |
Greece | Site Reference ID/Investigator# 62637 | Larisa | |
Greece | Site Reference ID/Investigator# 62638 | Larisa | |
Greece | Site Reference ID/Investigator# 62574 | Megara | |
Greece | Site Reference ID/Investigator# 62630 | N. Ionia Volou | |
Greece | Site Reference ID/Investigator# 62397 | Nea Erythraia | |
Greece | Site Reference ID/Investigator# 62385 | Nea Filadelfeia | |
Greece | Site Reference ID/Investigator# 62399 | Nea Smyrni | |
Greece | Site Reference ID/Investigator# 62582 | Nikaia | |
Greece | Site Reference ID/Investigator# 62585 | P. Faliro | |
Greece | Site Reference ID/Investigator# 62393 | Paiania | |
Greece | Site Reference ID/Investigator# 62394 | Pallini | |
Greece | Site Reference ID/Investigator# 62522 | Panorama | |
Greece | Site Reference ID/Investigator# 62492 | Patras | |
Greece | Site Reference ID/Investigator# 62501 | Patras | |
Greece | Site Reference ID/Investigator# 62502 | Patras | |
Greece | Site Reference ID/Investigator# 62579 | Peiraias | |
Greece | Site Reference ID/Investigator# 62401 | Peristeri | |
Greece | Site Reference ID/Investigator# 62402 | Peristeri | |
Greece | Site Reference ID/Investigator# 62578 | Peristeri | |
Greece | Site Reference ID/Investigator# 62388 | Peuki | |
Greece | Site Reference ID/Investigator# 62396 | Peuki | |
Greece | Site Reference ID/Investigator# 62520 | Polykastro | |
Greece | Site Reference ID/Investigator# 62495 | Pyrgos | |
Greece | Site Reference ID/Investigator# 62496 | Pyrgos | |
Greece | Site Reference ID/Investigator# 62510 | Rodes | |
Greece | Site Reference ID/Investigator# 62590 | Rodes | |
Greece | Site Reference ID/Investigator# 62592 | Rodes | |
Greece | Site Reference ID/Investigator# 62640 | Sappes Komotinis | |
Greece | Site Reference ID/Investigator# 62641 | Serres | |
Greece | Site Reference ID/Investigator# 62513 | Sykies | |
Greece | Site Reference ID/Investigator# 62509 | Thermi, Thessaloniki | |
Greece | Site Reference ID/Investigator# 62514 | Thessaloniki | |
Greece | Site Reference ID/Investigator# 62516 | Thessaloniki | |
Greece | Site Reference ID/Investigator# 62517 | Thessaloniki | |
Greece | Site Reference ID/Investigator# 62521 | Thessaloniki | |
Greece | Site Reference ID/Investigator# 62523 | Thessaloniki | |
Greece | Site Reference ID/Investigator# 62506 | Veria | |
Greece | Site Reference ID/Investigator# 62627 | Volos | |
Greece | Site Reference ID/Investigator# 62634 | Volos | |
Greece | Site Reference ID/Investigator# 62486 | Vraxnaiika | |
Greece | Site Reference ID/Investigator# 62387 | Vyronas | |
Greece | Site Reference ID/Investigator# 62485 | Xanthi | |
Greece | Site Reference ID/Investigator# 62488 | Xanthi |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions. | The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions. Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)] |
Baseline up to 6 months | No |
Primary | The Absolute Change in Systolic Blood Pressure From Baseline | The absolute change in systolic Blood Pressure from baseline | Baseline up to 6 months | No |
Secondary | Change in Framingham Stroke Risk Profile Scores of the Participating Patients | The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke. First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al. The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke. |
Baseline up to 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |