Last updated: February 7, 2023
Sponsor: Apsen Farmaceutica S.A.
Overall Status: Completed
Phase
3
Condition
Low Blood Pressure (Hypotension)
Dizzy/fainting Spells
Treatment
N/AClinical Study ID
NCT02112578
APS 002/2013
BRA15APS002-2015
U1111-1149-6768
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men and women aged over 18 years and less than 65;
- Presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the VS range ;
- Participants who are able to swallow tablets / capsules;
- Participants able to understand the guidance and care of this study and cooperative ;
- Participants with the requisite understanding, in accordance with Good ClinicalPractice Research Document of the Americas.
Exclusion
Exclusion Criteria:
- Use of meclizine or dimenidrynate in the actual event or in the past 15 days;
- Use of alcohol in the past 48 hours;
- Presence of vomiting which prevent the ingestion of tablets;
- Pregnancy or breastfeeding;
- Presence of clinical condition that determines contraindication to the activesubstances : convulsions , suspected intracranial compressive processes , closed-angleglaucoma , prostatic adenoma with urinary disorders , liver diseases , endocrine ,renal, and / or uncontrolled cardiovascular , Parkinson's disease, porphyria, knowhistory of hipersensibility to the Actives or Excipients from the study medications;
- Malignancies History , even if no evidence of active disease for less than five years . Those without active disease for more than five years may be included;
- Uncontrolled systemic arterial hypertension ( > 140/90 mmHg );
- Decompensated diabetes mellitus (blood glucose at any time > 200 mg / dL );
- Participants with asthma or chronic obstructive pulmonary disease;
- Participants making use of antihistamines with anti-vertigo effect ( betahistine,meclizine , diphenidol ) , drugs with antagonist calcium channel action ( cinnarizine , flunarizine ) , anticholinergic drugs ( metoclopramide , dimenhydrinate , meclizine , diphenidol , scopolamine, ondansetron, granisetron ) , antiseizure drugs ( diazepam , clonazepam , carbamazepine ) and other central nervous system depressants;
- Participants with central origin vertigo or non-vestibular;
- Participants with positional benign positional paroxysmal vertigo (bppv).
Study Design
Total Participants: 292
Study Start date:
November 01, 2016
Estimated Completion Date:
December 01, 2017
Study Description
Connect with a study center
IPO - Parana Otorhinolaryngology Institute
Curitiba, Parana 80610-010
BrazilSite Not Available
Clinilive
Maringá, Paraná
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, SP
BrazilSite Not Available
Alergoalpha
Barueri, São Paulo 06454010
BrazilSite Not Available
Pesquisare Saude S/S Ltda
Santo André, São Paulo 09080110
BrazilSite Not Available
Clinica de Alergia MarttiAntila
Sorocaba, São Paulo 18040425
BrazilSite Not Available
ISPEM
São José dos Campos, São Paulo 12243280
BrazilSite Not Available
CCBR SP
São Paulo, 04063001
BrazilSite Not Available
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