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Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial (ALERT)

P

PharmEvo

Status

Completed

Conditions

Essential Hypertension

Treatments

Drug: Valsartan, Amlodipine -

Study type

Observational

Funder types

Industry

Identifiers

NCT03371797
PE/PK/ALERT/SP/2017-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient whose BP is >139/89mmHg and on monotherapy with minimum last 30 days
  • Male or female aged (18 years - 70 Years)
  • Signed informed consent

Exclusion criteria

  • Secondary Hypertension
  • Pregnant or Lactating mother
  • Hypersensitivity to any active ingredient
  • Peripheral artery disease
  • Hepatic disease or biliary tract obstruction
  • Chronic kidney disease

Trial design

800 participants in 1 patient group

Treatment group
Description:
Valsartan, Amlodipine single pill combination.The recommended dosage of AVSAR (Valsartan/Amlodipine) is one tablet per day.
Treatment:
Drug: Valsartan, Amlodipine -

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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