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| Name | Class |
|---|---|
| Laboratorios Richmond Colombia SAS | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 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). |
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| Group 2 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with nifedipine | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAIMED | ChÃa | Cundinamarca | 250001 | Colombia |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2023 | Feb 26, 2026 |
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Randomized controlled clinical trial, 2x2 crossover
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| 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 |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 23, 2023 | Feb 26, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D009543 | Nifedipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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