Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-20

Study Completion Date

2018-11-05

Brief Summary

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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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Detailed Description

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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

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Essential Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment group

Valsartan, Amlodipine single pill combination.The recommended dosage of AVSAR (Valsartan/Amlodipine) is one tablet per day.

Valsartan, Amlodipine -

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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AVSAR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No