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
1 other identifier
observational
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2017
CompletedFirst Posted
Study publicly available on registry
December 13, 2017
CompletedStudy Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2018
CompletedNovember 8, 2018
December 1, 2017
7 months
December 8, 2017
November 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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 Outcomes (2)
Measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week
8 weeks
Participants experiencing adverse effect after taking single pill combination
8 weeks
Study Arms (1)
Treatment group
Valsartan, Amlodipine single pill combination.The recommended dosage of AVSAR (Valsartan/Amlodipine) is one tablet per day.
Interventions
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.
Eligibility Criteria
Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both
You may qualify if:
- 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
You may not qualify if:
- Secondary Hypertension
- Pregnant or Lactating mother
- Hypersensitivity to any active ingredient
- Peripheral artery disease
- Hepatic disease or biliary tract obstruction
- Chronic kidney disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmEvo Pvt Ltdlead
Study Sites (1)
Medicell
Karachi, Sindh, 75290, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tasneem Ahsan, MBBS
PharmEvo Pvt Ltd
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2017
First Posted
December 13, 2017
Study Start
February 20, 2018
Primary Completion
October 1, 2018
Study Completion
November 5, 2018
Last Updated
November 8, 2018
Record last verified: 2017-12