Clinical trial NCT03371797: Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial
Official title: Efficacy and Safety of Single Pill Combination (Amlodipine/Valsartan) in Hypertensive Patients Not Controlled on Previous Monotherapy: An Observational Real Life Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: ALERT, MSSBP, MSDBP
Lead sponsor: PharmEvo Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2017-12-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: Measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week
timeFrame: 8 weeks
measure: Participants experiencing adverse effect after taking single pill combination
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Medicell
state: Sindh
Study officials:
affiliation: PharmEvo Pvt Ltd
name: Tasneem Ahsan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: