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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CAIMED
Chía, Cundinamarca, Colombia
Start Date
July 9, 2024
Primary Completion Date
April 15, 2025
Completion Date
August 13, 2025
Last Updated
March 4, 2026
50
ACTUAL participants
Treatment with nifedipine
DRUG
Lead Sponsor
Laboratorios Richmond S.A.C.I.F.
Collaborators
Data Source & Attribution
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