PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND S… (NCT07448506) | Clinical Trial Compass
CompletedPhase 3
PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NIFEDIPINE 30MG EXTENDED-RELEASE IN ADULT PATIENTS DIAGNOSED WITH MILD OR MODERATE HYPERTENSION IN COLOMBIA.
Colombia50 participantsStarted 2024-07-09
Plain-language summary
To evaluate the efficacy of Nifedipine 30mg Extended-Release Richmond versus Nifedipine 30mg extended-release with a current registration in Colombia, measured by the proportion of patients with controlled blood pressure in adult patients diagnosed with mild or moderate hypertension at week 8 of follow-up.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged 18 years or older
* Confirmed diagnosis of mild-to-moderate primary hypertension according to ESC/ESH Guidelines (12), with blood pressure readings of systolic blood pressure (SBP) \< 140 mmHg or diastolic blood pressure (DBP) \< 90 mmHg
* Patient with controlled blood pressure readings during the last 4 weeks of enrollment, verified by medical records, according to ESC/ESH Guidelines (12).
* Use of nifedipine as monotherapy is preferred, or in combination therapy according to clinical judgment (maintaining the combination throughout the study without changing the nifedipine dose or the doses of concomitant medications the patient is currently taking).
* Voluntary participation with written informed consent.
Exclusion Criteria:
* Contraindication for Nifedipine use according to the established safety profile (as per the literature - Investigator's Manual):
* History of documented hypertensive encephalopathy in the medical record
* Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism (except hypothyroidism/controlled hyperthyroidism), and obstructive sleep apnea
* History of a diagnosis or condition that, in the investigator's judgment, may affect patient safety. • History of severe allergies to any medication
* Subject with heart failure, New York Heart Association (NYHA) class III or IV
* Severe coronary artery disease manifested by a history of myocardial infarction or unstable a…