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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02572219 |
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Date of registration:
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06/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients
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Scientific title:
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Effects of a Nutraceutical Preparation on Cognitive Impairment in Hypertensive Patients |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02572219 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent;
- Males or females between 40 and 65 years of age;
- Hypertensive patients classified according to their SBP (Systolic Blood Pressure) and
DBP (Diastolic Blood Pressure) values. Included patients will be those with stage 1
hypertension (SBP 140-159 mmHg; DBP 90-99 mmHg) and with stage 2 hypertension (SBP
160-179 mmHg; DBP 100-109 mmHg).
Exclusion Criteria:
- Previous acute myocardial infarction (AMI);
- Previous stroke and/or transient ischemic attack (TIA);
- Diabetes mellitus;
- History of atrial fibrillation or other severe arrhythmias;
- Severe cardiovascular diseases;
- Renal pathologies (creatinine > 1.4 mg/dL);
- Preexisting psychiatric pathologies;
- Neurodegenerative diseases, such as multiple sclerosis, lateral amyotrophic sclerosis,
Parkinson, Alzheimer, neuromuscular pathologies, epilepsy;
- Diagnosis of dementia;
- Depression;
- Long-term regular use of anxiolytics drugs, antidepressant drugs, antipsychotic drugs,
hypnoinducing drugs, cognitive stimulators.
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Nutraceutical compound
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Primary Outcome(s)
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Cognitive function assessed by neuropsychological tests
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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