Essential HypertensionALERTNCT03371797
Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial
An observational study of Essential Hypertension, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Valsartan, Amlodipine -
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2018to 5 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both
Who may be able to join
- 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
Who cannot join
- Secondary Hypertension
- Pregnant or Lactating mother
- Hypersensitivity to any active ingredient
- Peripheral artery disease
- Hepatic disease or biliary tract obstruction
- Chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Valsartan, Amlodipine -
- Keywords
- ALERT, MSSBP, MSDBP
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan, Amlodipine -Drug
Also called AVSAR
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Valsartan, Amlodipine single pill combination.The recommended dosage of AVSAR (Valsartan/Amlodipine) is one tablet per day. Receives: Drug: Valsartan, Amlodipine - |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 8 weeks
Secondary outcomes (2)
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]
Measured: 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]
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start20 Feb 2018
- Primary completion1 Oct 2018
- Study completion5 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmEvo Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tasneem Ahsan, MBBS, Principal investigator, PharmEvo Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371797
- Sponsor's protocol ID
- PE/PK/ALERT/SP/2017-01
- Acronym
- ALERT
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2017
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Single Pill Combination (Amlodipine/Valsartan) in Hypertensive Patients Not Controlled on Previous Monotherapy: An Observational Real Life Study
- ClinicalTrials.gov ID
- NCT03371797
- Acronym / sponsor ID
- ALERT / PE/PK/ALERT/SP/2017-01
- Conditions
- Essential Hypertension
- Keywords
- ALERT, MSSBP, MSDBP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- PharmEvo Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: Valsartan, Amlodipine -Valsartan, Amlodipine single pill combination.The recommended dosage of AVSAR (Valsartan/Amlodipine) is one tablet per day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Secondary Hypertension
- Pregnant or Lactating mother
- Hypersensitivity to any active ingredient
- Peripheral artery disease
- Hepatic disease or biliary tract obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan, Amlodipine -Also: AVSARValsartan 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. | Drug | Treatment group |
Primary outcome
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]
2 secondary outcomes
Measure percentage of participant with blood pressure change of <139/89 mmHg at the end of 8 week
Time frame: 8 weeks
Participants experiencing adverse effect after taking single pill combination
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasneem Ahsan, MBBS principal investigator
PharmEvo Pvt Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by PharmEvo Pvt Ltd at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.