NCT03371797

Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial

Efficacy and Safety of Single Pill Combination (Amlodipine/Valsartan) in Hypertensive Patients Not Controlled on Previous Monotherapy: An Observational Real Life Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: PharmEvo Pvt Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy of valsartan/amlodipine 80/5 mg once daily dose is reducing mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) after 8 weeks of therapy.

Detailed description

Avsar in tablet form which contains two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland International studies are available concerning the single pill combination therapy used in Blood pressure reduction. To determine the clinical significance of single pill combination, conducted multi center real life study i.e.; "ALERT Trial" in our local population. Through this study, observed the effect of single pill combination on BP reduction and adverse events in health care settings. Antihypertensive drugs use in a single pill combination may further enhance BP control by reducing pill burden and improve patient compliance.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Valsartan, Amlodipine -	Valsartan is a non-peptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype used as an antihypertensive agent. Amlodipine besylate is a dihydropyridine long-acting calcium channel blocker.

Timeline

• Start date: 2018-02-20
• Primary completion: 2018-10-01
• Completion: 2018-11-05
• First posted: 2017-12-13
• Last updated: 2018-11-08

Locations

1 site across 1 country: Pakistan