Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial

Essential Hypertension Clinical Trial

— ALERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371797
• Other study ID #: PE/PK/ALERT/SP/2017-01
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: November 5, 2018

Study information

• Verified date: December 2017
• Source: PharmEvo Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: November 5, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Medicell	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
PharmEvo Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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