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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
30 mg administered orally once daily
30 mg administered orally once daily.
CAIMED
Chía, Cundinamarca, Colombia
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.
Time frame: 8 week follow up
Proportion of Patients With Controlled Blood Pressure at Week 4
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.
Time frame: 4 week follow up
Incidence of Adverse Events
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.
Time frame: 4 week follow up
Incidence of Serious Adverse Events
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.
Time frame: 8 week follow up
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