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Completed

NCT Number: NCT03371797

Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medicell

Karachi, Sindh, 75290, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valsartan, Amlodipine -

Drug

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.

Other names: AVSAR

Primary outcomes

  1. Efficacy of valsartan/amlodipine 80/5 mg once daily dose is reducing mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure after 8 weeks of therapy.

    Time frame: 8 weeks

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

    [Designated as safety issue: No]

Secondary outcomes

  1. Measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week

    Time frame: 8 weeks

    To measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week

    [Designated as safety issue: No]

  2. Participants experiencing adverse effect after taking single pill combination

    Time frame: 8 weeks

    Proportion of participants experiencing adverse effect after taking single pill combination

    [Designated as safety issue: Yes]

Sponsors and collaborators

Lead sponsor

PharmEvo Pvt Ltd

Industry

Registry information

Official study title

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

Acronym: ALERT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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