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.

NCT07448506 | Completed Phase 3

• 1 other identifier: NIF30-0120
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

High Blood Pressure (& [Essential Hypertension])

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Secondary Outcome

  4 week follow up

• Secondary Outcome

  8 week follow up

• Secondary Outcome

  8 week follow up

Study Arms (2)

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).

Drug: Treatment with nifedipine

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).

Drug: Treatment with nifedipine

Interventions

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorios Richmond S.A.C.I.F.: lead
• Laboratorios Richmond Colombia SAS: collaborator

Study Sites (1)

CAIMED

Chía, Cundinamarca, 250001, Colombia

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Therapeutics; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial, 2x2 crossover

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 4, 2026
• Study Start: July 9, 2024
• Primary Completion: April 15, 2025
• Study Completion: August 13, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)