Phase
Condition
Stress
Vascular Diseases
Williams Syndrome
Treatment
candesartan cilexetil + chlorthalidone + amlodipine
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Both genders aged 18 years or older;
- Currently on dual antihypertensive therapy for at least 8 weeks, and non responders tothat treatment, defined as measurements of SBP ≥ 140 mmHg and ≤180 mmHg and/orDBP≥90mmHg and ≤110 mmHg, assessed at the screening visit and randomization visit (both conditions are in accordance with the Brazilian Hypertension Guideline - 2020);
- Able to understand and consent to their participation in this clinical trial,manifested by signing the Informed Consent Form;
Exclusion
Exclusion Criteria:
- Any significant clinical condition that, in the investigator's opinion, may interferewith participant safety;
- Any laboratory test finding that, in the investigator's opinion, may interfere withparticipant safety;
- Suspected or diagnosed with COVID 19;
- History of hypersensitivity to components of drugs used during the trial or to drugsderived from sulfonamides;
- Pregnant or breastfeeding women;
- Women in a reproductive age who do not agree to use contraceptive methods;
- Male participants who do not agree to use contraceptive methods;
- Participation in clinical trial protocols in the last 12 (twelve) months, unless theinvestigator judges that there may be a direct benefit to the participant;
- Participant who has some kind of relationship up to the second degree or bond withcollaborators or employees of the Sponsor and the Research site;
- Estimated glomerular filtration rate (eGFR) less than 45 ml/min /1.73m2 (calculated bythe Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) or end-stagerenal disease;
- Severe liver dysfunction;
- Cardiogenic shock or reduced ejection fraction heart failure with a left ventricularejection fraction less than or equal to 50%;
- Symptomatic congestive heart failure class II, III or IV, according to the New YorkHeart Association and/or participants with a history of infarction, unstable angina orcerebrovascular accident in the last 6 months prior to the beginning of the study;
- Clinically relevant ventricular cardiac arrhythmias;
- Obstructive coronary artery disease;
- Dementia syndrome;
- History of alcohol or illicit drug addiction in the six months prior to the date ofsignature of the Informed Consent Form;
- Obstructive biliary disorders;
- Refractory hypokalemia and/or conditions involving marked potassium loss,hyperkalemia, and/or hyponatremia;
- History of symptomatic hyperuricemia;
- History of secondary hypertension;
- History of cancer, without documentation of remission/cure;
Study Design
Study Description
Connect with a study center
Hospital de Urgência e Emergência de Rio Branco
Rio Branco, AC
BrazilSite Not Available
Centro de Pesquisas Clinicas Dr. Marco Mota (Centro Universitario Cesmac/ Hospital do Coração de Alagoas)
Maceió, Alagoas
BrazilSite Not Available
Centro de Pesquisas em Diabetes e Doenças Endócrino Metabólicas LTDA
Fortaleza, Ceará
BrazilSite Not Available
Vitoria Clinical Research Institute LTDA
Vitória, Espírito Santo
BrazilSite Not Available
Santa Casa de Misericórdia de Passos
Passos, MG
BrazilSite Not Available
Hospital Universitário Joao de Barros Barreto - UFPA
Belém, Pará
BrazilSite Not Available
Hospital 9 de Julho
Sao Paulo, Please Select
BrazilSite Not Available
Instituto Atena de Pesquisa Clinica LTDA
Natal, Rio Grande Do Norte
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul 90035-007
BrazilSite Not Available
Centro de Pesquisa Clínica do Coração
Aracaju, SE
BrazilSite Not Available
Hospital Universitário São Francisco de Assis
Bragança Paulista, SP
BrazilActive - Recruiting
Instituto de Pesquisa Clínica de Campinas
Campinas, SP
BrazilSite Not Available
Hospital M'Boi Mirim
São Paulo, SP
BrazilSite Not Available
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
Joinville, Santa Catarina
BrazilSite Not Available
LOEMA - Instituto de Pesquisa Clinica & Consultores LTDA.
Campinas, São Paulo
BrazilSite Not Available
Indacor Serviços Médicos
Indaiatuba, São Paulo
BrazilSite Not Available
CIPES Centro Internacional de Pesquisa Clínica LTDA
São José Dos Campos, São Paulo
BrazilSite Not Available
Clínica Cardiológica
Votuporanga, São Paulo
BrazilSite Not Available
Santa Casa de Misericordia de Votuporanga
Votuporanga, São Paulo
BrazilSite Not Available
Hospital Universitário Pedro Ernesto/UERJ
Rio De Janeiro,
BrazilSite Not Available
Associação Lar São Francisco de Assis na Providência de Deus
São Paulo,
BrazilSite Not Available
InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
São Paulo, 05403-900
BrazilSite Not Available
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