A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension
Overview
- Phase
- Phase 3
- Intervention
- candesartan cilexetil + chlorthalidone + amlodipine
- Conditions
- Hypertension
- Sponsor
- Hospital Israelita Albert Einstein
- Enrollment
- 702
- Locations
- 22
- Primary Endpoint
- Mean change in systolic blood pressure (SBP)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of a new combination of 3 (three) antihypertensive drugs in a single pill (candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg) compared with another combination of 3 (three) antihypertensive drugs (Exforge HCT® [valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg]). This will be a non-inferiority trial and the primary outcome will be blood pressure control after 12 weeks of treatment.
Detailed Description
This phase III, multicenter, randomized, double-blind, controlled, parallel trial will evaluate the non-inferiority of the association between candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg in relation to Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12 5mg + amlodipine 5mg) in the treatment of systemic arterial hypertension. A total of 698 participants will be included. Follow-up visits will occur four, eight, and twelve weeks after the date of the randomization visit. A telephone contact will be performed 30 days after the end of treatment. The primary efficacy outcome is the mean change in blood pressure, measured at the research site, 12 weeks after starting treatment, compared to baseline. Incidence of adverse events will be collected from the first dose of treatment up to 30 days after the end of the treatment foreseen in the protocol.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Both genders aged 18 years or older;
- •Currently on dual antihypertensive therapy for at least 8 weeks, and non responders to that treatment, defined as measurements of SBP ≥ 140 mmHg and ≤180 mmHg and/or DBP≥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 Criteria
- •Any significant clinical condition that, in the investigator's opinion, may interfere with participant safety;
- •Any laboratory test finding that, in the investigator's opinion, may interfere with participant safety;
- •Suspected or diagnosed with COVID 19;
- •History of hypersensitivity to components of drugs used during the trial or to drugs derived 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 the investigator 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 with collaborators or employees of the Sponsor and the Research site;
- •Estimated glomerular filtration rate (eGFR) less than 45 ml/min /1.73m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation) or end-stage renal disease;
Arms & Interventions
Association of candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg
The participant will take, once a day, 01 tablet of the active experimental drug (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg), plus 01 placebo, both orally.
Intervention: candesartan cilexetil + chlorthalidone + amlodipine
Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
The participant will take 01 tablet of Exforge HCT® active comparator (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) plus 01 placebo, both orally.
Intervention: Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Outcomes
Primary Outcomes
Mean change in systolic blood pressure (SBP)
Time Frame: 12 weeks
The primary efficacy endpoint is the mean change in systolic blood pressure, measured at the site, 12 weeks after starting treatment, compared to baseline.
Secondary Outcomes
- Participants with SBP <120 mmHg(12 weeks)
- Participants with reduction greater than or equal to 20 mmHg in SBP(12 weeks)
- Participants with reduction greater than or equal to 10 mmHg in DBP(12 weeks)
- Mean change in diastolic blood pressure (DBP)(12 weeks)
- Participants with blood pressure (SBP <140 and DBP<90 mmHg)(12 weeks)
- Participants with SBP <140 mmHg(12 weeks)
- Participants with DBP<90 mmHg(12 weeks)