High Blood Pressure (& [Essential Hypertension])Phase 3NCT07448506
Nifedipine Extended-Release in Patients With Mild or Moderate Hypertension
A Phase 3 study testing Treatment with Nifedipine 30 mg Extended-Release (Richmond) and Comparator Nifedipine 30 mg Extended-Release in people with High Blood Pressure (& [Essential Hypertension]), run by Laboratorios Richmond S.A.C.I.F. at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Blood Pressure (& [Essential Hypertension])
- What is being tested?
- Treatment with Nifedipine 30 mg Extended-Release (Richmond) and Comparator Nifedipine 30 mg Extended-Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteColombia
- Study dates
- 9 Jul 2024to 13 Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of Nifedipine 30 mg Extended-Release in Adult Patients Diagnosed With Mild or Moderate Hypertension in Colombia
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.
Read the 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.
- Being tested
- Treatment with Nifedipine 30 mg Extended-Release (Richmond), Comparator Nifedipine 30 mg Extended-Release
- Keywords
- Hypertension, Nifedipine, Nifedipine Extended-Release, Calcium Channel Blocker, Antihypertensive Agents, Phase III, Adult Patients, Adults with Hypertension, Blood Pressure Reduction, Antihypertensive Efficacy, Colombia, Latin America
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Nifedipine 30 mg Extended-Release (Richmond)Drug
30 mg administered orally once daily
Comparator Nifedipine 30 mg Extended-ReleaseDrug
30 mg administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine ER followed by Comparator | Experimental | Participants receive Nifedipine ER 30 mg orally once daily for 8 weeks, followed by Comparator Nifedipine 30 mg orally once daily for 10 weeks. Receives: Drug: Treatment with Nifedipine 30 mg Extended-Release (Richmond); Drug: Comparator Nifedipine 30 mg Extended-Release |
| Comparator followed by Nifedipine ER) | Experimental | Participants receive Comparator Nifedipine 30 mg orally once daily for 8 weeks, followed by Nifedipine ER 30 mg orally once daily for 10 weeks. Receives: Drug: Treatment with Nifedipine 30 mg Extended-Release (Richmond); Drug: Comparator Nifedipine 30 mg Extended-Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week follow up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 8 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start9 Jul 2024
- Primary completion15 Apr 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood Pressure (& [Essential Hypertension])Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized controlled clinical trial, 2x2 crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Richmond S.A.C.I.F.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorios Richmond Colombia SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448506
- Sponsor's protocol ID
- NIF30-0120
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Active-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of Nifedipine 30 mg Extended-Release in Adult Patients Diagnosed With Mild or Moderate Hypertension in Colombia
- ClinicalTrials.gov ID
- NCT07448506
- Acronym / sponsor ID
- NIF30-0120
- Keywords
- Hypertension, Nifedipine, Nifedipine Extended-Release, Calcium Channel Blocker, Antihypertensive Agents, Phase III, Adult Patients, Adults with Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Laboratorios Richmond S.A.C.I.F.Industry (pharma, biotech, devices)
- Collaborators
- Laboratorios Richmond Colombia SAS
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial, 2x2 crossover
| Arm | Type | Receives |
|---|---|---|
| Nifedipine ER followed by Comparator | Experimental | Drug: Treatment with Nifedipine 30 mg Extended-Release (Richmond), Drug: Comparator Nifedipine 30 mg Extended-ReleaseParticipants receive Nifedipine ER 30 mg orally once daily for 8 weeks, followed by Comparator Nifedipine 30 mg orally once daily for 10 weeks. |
| Comparator followed by Nifedipine ER) | Experimental | Drug: Treatment with Nifedipine 30 mg Extended-Release (Richmond), Drug: Comparator Nifedipine 30 mg Extended-ReleaseParticipants receive Comparator Nifedipine 30 mg orally once daily for 8 weeks, followed by Nifedipine ER 30 mg orally once daily for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with Nifedipine 30 mg Extended-Release (Richmond)30 mg administered orally once daily | Drug | Comparator followed by Nifedipine ER), Nifedipine ER followed by Comparator |
| Comparator Nifedipine 30 mg Extended-Release30 mg administered orally once daily. | Drug | Comparator followed by Nifedipine ER), Nifedipine ER followed by Comparator |
Primary outcome
Main Outcome
Time frame: 8 week follow up
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.
3 secondary outcomes
Proportion of Patients With Controlled Blood Pressure at Week 4
Time frame: 4 week follow up
Incidence of Adverse Events
Time frame: 4 week follow up
Incidence of Serious Adverse Events
Time frame: 8 week follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment with Nifedipine 30 mg Extended-Release (Richmond) and Comparator Nifedipine 30 mg Extended-Release in people with High Blood Pressure (& [Essential Hypertension]), run by Laboratorios Richmond S.A.C.I.F. at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Outcome (time frame: 8 week follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.