Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of Nifedipine 30 mg Extended-Release in Adult Patients Diagnosed With Mild or Moderate Hypertension in Colombia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Main Outcome
Study Overview
Brief 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.
Detailed Description
Main Objective - To evaluate the efficacy of Nifedipine 30mg Extended-Release Richmond versus Nifedipine 30mg extended-release comparator with 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.
Primary Evaluation Criterion: Blood pressure control (SBP/DBP) at 8 weeks of follow-up
Secondary Objectives
- To evaluate the efficacy of Nifedipine 30mg Extended-Release Richmond versus Nifedipine 30mg extended-release comparator with 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 4 of follow-up.
Evaluation Criterion: Blood pressure control (SBP/DBP) at 4 weeks of follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 angina within the 6 months prior to visit 1
- •Valvular heart disease "Valvular heart disease with symptoms (dyspnea, syncope, or chest pain) documented in current medical history"
- •History of malignancy within the past 5 years, excluding skin or basal cell carcinoma
- •Surgical or medical conditions that may alter the metabolism, excretion, or distribution or absorption of any drug.
- •Gastrointestinal disease or surgery that may result in malabsorption.
- •Severe narrowing of the gastrointestinal tract; Kock bag (ileostomy after proctocolectomy).
- •Cholestasis or biliary obstruction, or history of pancreatic injury, or clinically significant elevation of lipase, amylase, or bilirubin.
- •Transaminase levels (AST and ALT) > 3 x ULN.
- •Renal insufficiency, defined as eGFR <30 mL/min (calculated using the Cockcroft-Gault formula) or on hemodialysis.
- •Participation in another research trial
- •Pregnant women
- •Subjects with an aortic aneurysm who, in the investigator's opinion, are not suitable for inclusion in the study.
- •Considered by the investigator for any reason unsuitable to participate in a clinical study Use of everolimus and pimozide.
- •History of noncompliance, alcoholism, or drug abuse that, in the investigator's opinion, will compromise the successful completion of the study.
- •Use and indication of the following medications: alosetron, cisapride, anti-obesity preparations (fenfluramide, dexfenfluramide, phentermine), troglitazone, systemic anabolic steroids, coagulation factors, doxazosin, terbinafine, isotretinoin, itraconazole, celecoxib, phenytoin, centrally acting sympathomimetic drugs, mefloquine, phenylpropanolamine.
Arms & Interventions
Comparator followed by Nifedipine ER)
Participants receive Comparator Nifedipine 30 mg orally once daily for 8 weeks, followed by Nifedipine ER 30 mg orally once daily for 10 weeks.
Intervention: Treatment with Nifedipine 30 mg Extended-Release (Richmond) (Drug)
Nifedipine ER followed by Comparator
Participants receive Nifedipine ER 30 mg orally once daily for 8 weeks, followed by Comparator Nifedipine 30 mg orally once daily for 10 weeks.
Intervention: Treatment with Nifedipine 30 mg Extended-Release (Richmond) (Drug)
Nifedipine ER followed by Comparator
Participants receive Nifedipine ER 30 mg orally once daily for 8 weeks, followed by Comparator Nifedipine 30 mg orally once daily for 10 weeks.
Intervention: Comparator Nifedipine 30 mg Extended-Release (Drug)
Comparator followed by Nifedipine ER)
Participants receive Comparator Nifedipine 30 mg orally once daily for 8 weeks, followed by Nifedipine ER 30 mg orally once daily for 10 weeks.
Intervention: Comparator Nifedipine 30 mg Extended-Release (Drug)
Outcomes
Primary Outcomes
Main Outcome
Time Frame: 8 week follow up
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.
Secondary Outcomes
- Proportion of Patients With Controlled Blood Pressure at Week 4(4 week follow up)
- Incidence of Adverse Events(4 week follow up)
- Incidence of Serious Adverse Events(8 week follow up)