NCT07448506

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Laboratorios Richmond S.A.C.I.F. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. \- 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.

Conditions

• High Blood Pressure (& [Essential Hypertension])

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-09
• Primary completion: 2025-04-15
• Completion: 2025-08-13
• First posted: 2026-03-04
• Last updated: 2026-03-04

Locations

1 site across 1 country: Colombia