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

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

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Valsartan, Amlodipine -

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.

• Study Type: Observational
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75290
      • Medicell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; Valsartan, Amlodipine single pill combination.The recommended dosage of AVSAR (Valsartan/Amlodipine) is one tablet per day.	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.; Other Names: AVSAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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]	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week	To measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week [Designated as safety issue: No]	8 weeks
Participants experiencing adverse effect after taking single pill combination	Proportion of participants experiencing adverse effect after taking single pill combination [Designated as safety issue: Yes]	8 weeks

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Investigators: Principal Investigator: Tasneem Ahsan, MBBS, PharmEvo Pvt Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2018
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): November 5, 2018

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (ACTUAL): December 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: ALERT, MSSBP, MSDBP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Valsartan
• Other Study ID Numbers: PE/PK/ALERT/SP/2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No