At a glance
ClinicalIndex Comparison Record- ✓Grade 1-2 hypertensive patients with mean sitting SBP ≥140 and ≤179 mmHg and/or mean sitting DBP ≥90 and ≤109 mmHg at screening
- ✓Age 18-65 years
- ✓Currently on monotherapy with zofenopril 30 mg, amlodipine 5 mg, or other ACE inhibitor or calcium channel blocker (felodipine, isradipine, lacidipine, lercanidipine, nicardipine, nifedipine, nisoldipine) for at least 1 month before screening
- ✓Able to understand and give written informed consent
- ✕Known contraindications, hypersensitivity, or significant history of allergy to zofenopril, amlodipine, ACE inhibitors, dihydropyridines, or related products
- ✕Serious disorders limiting ability to evaluate efficacy or safety, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine/metabolic, hematological, oncological, neurological, or psychiatric diseases
- ✕History within 6 months of myocardial infarction, unstable angina, percutaneous coronary intervention, bypass surgery, valve replacement, cerebrovascular accident, stroke, heart failure, hypertensive encephalopathy, or transient ischemic attack
- ✕Secondary hypertension of any etiology (renal disease, pheochromocytoma, Cushing's syndrome, hyperaldosteronism, renovascular disease, thyroid disorders)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interventional Clinical Trial to Assess Efficacy and Safety of the Extemporaneous Combination of Zofenopril Calcium and Amlodipine in Grade 1-2 Hypertensive Patients Versus Each Monotherapy - (MASOLINO Study)
In Brief
A Phase 4 clinical trial evaluating Zofenopril and Amlodipine for Hypertension. Completed, enrolled 277 participants across 1 site.
Detailed Summary
Study to assess the anti-hypertensive efficacy and safety of the extemporaneous combination of Zofenopril 30 mg in combination with Amlodipine 5 mg or AML 10 mg in lowering the sitting diastolic BP after 8 weeks of treatment in patients with uncontrolled BP previously treated with Zofenopril or Amlodipine (5 mg) monotherapies for at least 4 weeks.
Study Details
Timeline
Interventions
Film-Coated tablets administered orally once daily according instructions provided by Principal Investigator.
Tablets of 5mg and 10mg administered orally once daily according instructions provided by Principal Investigator.