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.

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.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure (& [Essential Hypertension])
• Intervention / Treatment: Drug: Treatment with nifedipine

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.

- To evaluate the safety of Nifedipine 30mg Extended-Release Richmond versus the active comparator, measured by the proportion of adverse events identified during follow-up.

Evaluation Criterion: Cumulative safety data.

- To evaluate the safety of Nifedipine 30mg Extended-Release Richmond versus the active comparator, measured by the proportion of serious adverse events identified during follow-up.

Evaluation Criterion: Cumulative safety data.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Chía, Cundinamarca, Colombia, 250001
      • CAIMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Administration of Nifedipine 30mg Extended Release Richmond, for 8 weeks, treatment is changed to Nifedipine comparator "according to the current medical prescription" for 10 weeks (2 weeks of statistical silence are included).	Drug: Treatment with nifedipine; Administration 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.
Experimental: Group 2; Administration of Nifedipine 30mg Richmond Extended Release, for 8 weeks, treatment is changed to Nifedipine comparator "according to the current medical formula" for 10 weeks (2 weeks of statistical silence are included).	Drug: Treatment with nifedipine; Administration 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Outcome	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.	8 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome	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 4 of follow-up.	4 week follow up
Secondary Outcome	To evaluate the safety of Nifedipine 30mg Extended-Release Richmond versus an active comparator, measured by the proportion of adverse events identified during follow-up.	8 week follow up
Secondary Outcome	To evaluate the safety of Nifedipine 30mg Extended Release Richmond versus an active comparator, measured by the proportion of serious adverse events identified during follow-up.	8 week follow up

Collaborators and Investigators

• Sponsor: Laboratorios Richmond S.A.C.I.F.
• Collaborators: Laboratorios Richmond Colombia SAS

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): August 13, 2025

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Phase III; Adult Patients; Nifedipine; Calcium Channel Blocker; Antihypertensive Agents; Colombia; Latin America; Blood Pressure Reduction; Nifedipine Extended-Release; Adults with Hypertension; Antihypertensive Efficacy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Nifedipine; Therapeutics
• Other Study ID Numbers: NIF30-0120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study is registered to comply with regulatory requirements in Colombia. The Sponsor has not established a plan to share individual participant data (IPD) at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No