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.
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.
\- 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.