Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension (OPTION TREAT)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05920005 |
Recruitment Status :
Recruiting
First Posted : June 27, 2023
Last Update Posted : August 24, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: candesartan cilexetil + chlorthalidone + amlodipine Drug: Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 698 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A multicenter, double-blind, phase III, parallel, controlled and randomized clinical trial. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The experimental/comparator drug has different characteristics. To allow blinding, the Double-Dummy method will be performed, where study sites will receive two drug presentations (active and placebo), thus preventing any violation of blinding. |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Double-blind, Controlled, Randomized Trial to Evaluate the Association Candesartan Cilexetil + Chlorthalidone + Amlodipine Versus Exforge HCT®️ for Systemic Arterial Hypertension |
Actual Study Start Date : | August 22, 2023 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | July 1, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Drug: candesartan cilexetil + chlorthalidone + amlodipine
Antihypertensive drugs in a single tablet (association candesartan cilexetil 16mg + chlorthalidone 12.5mg + amlodipine 5mg) |
Active Comparator: 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.
|
Drug: Exforge HCT® (valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg)
Antihypertensive drugs in a single tablet (association valsartan 160mg + hydrochlorothiazide 12.5mg + amlodipine 5mg) |
- 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.
- Mean change in diastolic blood pressure (DBP) [ Time Frame: 12 weeks ]Variation in diastolic blood pressure 4, 6 and 12 weeks after starting treatment
- Participants with blood pressure (SBP <140 and DBP<90 mmHg) [ Time Frame: 12 weeks ]Proportion of participants who reach the target blood pressure (SBP <140 and DBP<90mmHg) 4, 8 and 12 weeks after starting treatment
- Participants with SBP <120 mmHg [ Time Frame: 12 weeks ]Proportion of participants who reach the target blood pressure of SBP <120 mmHg 4, 8 and 12 weeks after starting treatment
- Participants with SBP <140 mmHg [ Time Frame: 12 weeks ]Proportion of participants who reach target systolic blood pressure (SBP <140 mmHg) 4, 8 and 12 weeks after starting treatment
- Participants with DBP<90 mmHg [ Time Frame: 12 weeks ]Proportion of participants who reach the target diastolic blood pressure (DBP<90 mmHg) 4, 8 and 12 weeks after starting treatment
- Participants with reduction greater than or equal to 20 mmHg in SBP [ Time Frame: 12 weeks ]Proportion of participants who show a reduction greater than or equal to 20 mmHg in systolic blood pressure 4, 8 and 12 weeks after the start of treatment
- Participants with reduction greater than or equal to 10 mmHg in DBP [ Time Frame: 12 weeks ]Proportion of participants who have a reduction greater than or equal to 10 mmHg in diastolic blood pressure 4, 8 and 12 weeks after starting treatment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;
- Severe liver dysfunction;
- Cardiogenic shock or reduced ejection fraction heart failure with a left ventricular ejection fraction less than or equal to 50%;
- Symptomatic congestive heart failure class II, III or IV, according to the New York Heart Association and/or participants with a history of infarction, unstable angina or cerebrovascular 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 of signature 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;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920005
Contact: Vagner Madrini Junior, MD | +55 11 2151-5915 | vagner.junior@einstein.br | |
Contact: Diogo Moia, MD | +55 11 2151-5915 | diogo.moia@einstein.br |
Study Director: | Patrícia Oliveira Guimarães, MD, PhD | Hospital Israelita Albert Einstein |
Responsible Party: | Hospital Israelita Albert Einstein |
ClinicalTrials.gov Identifier: | NCT05920005 |
Other Study ID Numbers: |
LB2009 |
First Posted: | June 27, 2023 Key Record Dates |
Last Update Posted: | August 24, 2023 |
Last Verified: | June 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Hydrochlorothiazide Candesartan Candesartan cilexetil Chlorthalidone Amlodipine, Valsartan Drug Combination Antihypertensive Agents |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Diuretics Natriuretic Agents Sodium Chloride Symporter Inhibitors |