HypertensionPhase 4NCT06487949
Valsartan and Amlodipine in Blood Pressure Management: Fixed-Dose vs. Free Drug Therapy
A Phase 4 study testing valsartan-amlodipine 80/5 mg FDC and valsartan 80 mg and amlodipine 5 mg as free combination in people with Hypertension, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan-amlodipine 80/5 mg FDC and valsartan 80 mg and amlodipine 5 mg as free combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2022to 1 Dec 2023
- Phase
- Phase 4
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications
Who cannot join
- Patients previously been on antihypertensive drugs
- Patients had secondary high blood pressure
- Patients had severe high blood pressure (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg)
- Patients had ischemic heart disease in the past
- Patients were unable to receive any part of the treatment
- Patients who refuse to take part in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Valsartan 80 mg and Amlodipine 5 mg in Fixed-Dose Combination Therapy Versus Combination Free Drug Therapy for Ambulatory Blood Pressure Management: A Randomized Controlled Trial
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.
Read the detailed description
Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications.
This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.
Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.
- Conditions
- Hypertension
- Being tested
- valsartan-amlodipine 80/5 mg FDC, valsartan 80 mg and amlodipine 5 mg as free combination
- Keywords
- hypertension, 24 hours ambulatory blood pressure monitoring, fix dose combination
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan-amlodipine 80/5 mg FDCDrug
Also called FDC
fix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill
valsartan 80 mg and amlodipine 5 mg as free combinationDrug
Also called free drug combination
Free combination of valsartan 80 mg and amlodipine 5 mg given separately
| Study group | Role | What they receive |
|---|---|---|
| valsartan- Amlodipine fix dose combination pill | Experimental | Patients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill Receives: Drug: valsartan-amlodipine 80/5 mg FDC |
| Valsartan- Amlodipine free dose combination | Active comparator | Patients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately Receives: Drug: valsartan 80 mg and amlodipine 5 mg as free combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 24 hours systolic blood pressure
The average systolic blood pressure over 24 hours, during the day and at night
Measured: 8 weeks
Mean 24 hours diastolic blood pressure
The average diastolic blood pressure over 24 hours, during the day and at night
Measured: 8 weeks
Mean 24 hours mean blood pressure
The average mean blood pressure over 24 hours, during the day and at night
Measured: 8 weeks
Secondary outcomes (1)
Dipping
Drop of Mean systolic pressure more than 10% during nights compare to mean systolic pressure at days
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 posted5 Jul 2024
- Study start1 Dec 2022
- Primary completion1 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Kojuri, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487949
- Sponsor's protocol ID
- IR.SUMS.MED.REC.1400.505
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is available based on rational request
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Valsartan 80 mg and Amlodipine 5 mg in Fixed-Dose Combination Therapy Versus Combination Free Drug Therapy for Ambulatory Blood Pressure Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06487949
- Acronym / sponsor ID
- IR.SUMS.MED.REC.1400.505
- Conditions
- Hypertension
- Keywords
- hypertension, 24 hours ambulatory blood pressure monitoring, fix dose combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Jul 2024 (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.
Patients aged 35 to 70 years with newly diagnosed stage 1 or 2 hypertension ( HTN) was randomized to receive either Valsartan 80 mg/Amlodipine 5 mg fix dose combination (FDC) or a free equivalent combination. Ambulatory blood pressure monitoring at baseline and 8 weeks post-treatment initiation was performed.
Detailed description
Patients were eligible for enrollment if they were between 35 and 70 years old and diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications.
This study used the permutation block randomization method (block size = 4) for the randomization process.Patients were randomly assigned to either the FDC group or the free equivalent combination group.
Eligible patients underwent an 8-week period during which they received either Valsartan 80 mg and Amlodipine 5 mg as an FDC or as free equivalent combinations. The FDC group received one single tablet daily, while the free combination group received the medications on separate tablets (amlodipine daily and Valsartan in the evening). 24-hour ambulatory blood pressure monitoring (ABPM) at the time of inclusion and at the end of the 8-week period were performed using a standard ABPM device that the patients wore with an appropriately sized cuff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| valsartan- Amlodipine fix dose combination pill | Experimental | Drug: valsartan-amlodipine 80/5 mg FDCPatients with hypertension eligible receiving valsartan- Amlodipine 80/5 mg fix dose combination (FDC) pill |
| Valsartan- Amlodipine free dose combination | Active comparator | Drug: valsartan 80 mg and amlodipine 5 mg as free combinationPatients with hypertension eligible receiving valsartan 80 mg and amlodipine 5 mg as free dose of drugs separately |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with stage 1 or 2 hypertension at the time of enrollment, according to the 2017 ACC/AHA Guidelines (systolic blood pressure > 130 mmHg and/or diastolic blood pressure > 80 mmHg), and required the initiation of antihypertensive medications
Key exclusion criteria (6 listed)
- Patients previously been on antihypertensive drugs
- Patients had secondary high blood pressure
- Patients had severe high blood pressure (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg)
- Patients had ischemic heart disease in the past
- Patients were unable to receive any part of the treatment
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 80/5 mg FDCAlso: FDCfix dose combination of valsartan 80 mg and Amlodipine 5 mg given as single pill | Drug | valsartan- Amlodipine fix dose combination pill |
| valsartan 80 mg and amlodipine 5 mg as free combinationAlso: free drug combinationFree combination of valsartan 80 mg and amlodipine 5 mg given separately | Drug | Valsartan- Amlodipine free dose combination |
Primary outcome
Mean 24 hours systolic blood pressure
Time frame: 8 weeks
The average systolic blood pressure over 24 hours, during the day and at night
Mean 24 hours diastolic blood pressure
Time frame: 8 weeks
The average diastolic blood pressure over 24 hours, during the day and at night
Mean 24 hours mean blood pressure
Time frame: 8 weeks
The average mean blood pressure over 24 hours, during the day and at night
1 secondary outcome
Dipping
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 5 Jul 2024.
- Individual participant dataSharing planned: No. The data is available based on rational request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan-amlodipine 80/5 mg FDC and valsartan 80 mg and amlodipine 5 mg as free combination in people with Hypertension, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 1 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 5 Jul 2024. 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 Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean 24 hours systolic blood pressure (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 5 Jul 2024.