New study checks if a standard blood pressure pill works as well as the original
NCT ID NCT07448506
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tested a generic version of the blood pressure drug nifedipine against the brand-name version in 50 adults with mild-to-moderate high blood pressure in Colombia. The goal was to see if the generic pill controls blood pressure just as well after 8 weeks. Participants had to already have their blood pressure under control before joining. The results help confirm that cheaper generic options can be effective for managing hypertension long-term.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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50 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Aug 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men or women aged 18 years or older * Confirmed diagnosis of mild-to-moderate primary hypertension according to ESC/ESH Guidelines (12), with blood pressure readings of systolic blood pressure (SBP) \< 140 mmHg or diastolic blood pressure (DBP) \< 90 mmHg * Patient with controlled blood pressure readings during the last 4 weeks of enrollment, verified by medical records, according to ESC/ESH Guidelines (12). * Use of nifedipine as monotherapy is preferred, or in combination therapy according to clinical judgment (maintaining the combination throughout the study without changing the nifedipine dose or the doses of concomitant medications the patient is currently taking). * Voluntary participation with written informed consent. Exclusion Criteria: * Contraindication for Nifedipine use according to the established safety profile (as per the literature - Investigator's Manual): * History of documented hypertensive encephalopathy in the medical record * Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism (except hypothyroidism/controlled hyperthyroidism), and obstructive sleep apnea * History of a diagnosis or condition that, in the investigator's judgment, may affect patient safety. • History of severe allergies to any medication * Subject with heart failure, New York Heart Association (NYHA) class III or IV * Severe coronary artery disease manifested by a history of myocardial infarction or unstable angina within the 6 months prior to visit 1 * Valvular heart disease "Valvular heart disease with symptoms (dyspnea, syncope, or chest pain) documented in current medical history" * History of malignancy within the past 5 years, excluding skin or basal cell carcinoma * Surgical or medical conditions that may alter the metabolism, excretion, or distribution or absorption of any drug. * Gastrointestinal disease or surgery that may result in malabsorption. * Severe narrowing of the gastrointestinal tract; Kock bag (ileostomy after proctocolectomy). * Cholestasis or biliary obstruction, or history of pancreatic injury, or clinically significant elevation of lipase, amylase, or bilirubin. * Transaminase levels (AST and ALT) \> 3 x ULN. * Renal insufficiency, defined as eGFR \<30 mL/min (calculated using the Cockcroft-Gault formula) or on hemodialysis. * Participation in another research trial * Pregnant women * Subjects with an aortic aneurysm who, in the investigator's opinion, are not suitable for inclusion in the study. * Considered by the investigator for any reason unsuitable to participate in a clinical study Use of everolimus and pimozide. * History of noncompliance, alcoholism, or drug abuse that, in the investigator's opinion, will compromise the successful completion of the study. * Use and indication of the following medications: alosetron, cisapride, anti-obesity preparations (fenfluramide, dexfenfluramide, phentermine), troglitazone, systemic anabolic steroids, coagulation factors, doxazosin, terbinafine, isotretinoin, itraconazole, celecoxib, phenytoin, centrally acting sympathomimetic drugs, mefloquine, phenylpropanolamine.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CAIMED
Chía, Cundinamarca, 250001, Colombia
More trials for these conditions
Other studies related to the condition(s) this trial covers.