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Trial record 2 of 99 for:    AMLODIPINE AND VALSARTAN

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

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ClinicalTrials.gov Identifier: NCT03371797
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
PharmEvo Pvt Ltd

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.

Condition or disease Intervention/treatment
Essential Hypertension 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.

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Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Efficacy and Safety of Single Pill Combination (Amlodipine/Valsartan) in Hypertensive Patients Not Controlled on Previous Monotherapy: An Observational Real Life Study
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine


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 Name: AVSAR




Primary Outcome Measures :
  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 Outcome Measures :
  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]




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371797


Locations
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Pakistan
Medicell
Karachi, Sindh, Pakistan, 75290
Sponsors and Collaborators
PharmEvo Pvt Ltd
Investigators
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Principal Investigator: Tasneem Ahsan, MBBS PharmEvo Pvt Ltd

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Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT03371797     History of Changes
Other Study ID Numbers: PE/PK/ALERT/SP/2017-01
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PharmEvo Pvt Ltd:
ALERT, MSSBP, MSDBP
Additional relevant MeSH terms:
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Amlodipine
Valsartan
Amlodipine, Valsartan Drug Combination
Essential Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists