Arterial HypertensionPhase 4ONE&ONLYNCT02710539
Once-daily Fixed Combination of Three Antihypertensive Drugs
A Phase 4 study testing perindopril, indapamide , amlodipine and Tripliam (perindopril, indapamide, amlodipine) in people with Arterial Hypertension, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- perindopril, indapamide , amlodipine and Tripliam (perindopril, indapamide, amlodipine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with arterial hypertension resistant to monotherapy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)
Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension
Read the detailed description
The aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension
- Conditions
- Arterial Hypertension
- Being tested
- perindopril, indapamide , amlodipine, Tripliam (perindopril, indapamide, amlodipine)
- Keywords
- arterial hypertension, antihypertensive drugs
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perindopril, indapamide , amlodipineDrug
Also called Procaptan, Indapamide, Norvasc
Free combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
Tripliam (perindopril, indapamide, amlodipine)Drug
Also called Fixed combination of Procaptan, Indapamide, Norvasc
Fixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Free combination | Active comparator | Perindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy Receives: Drug: perindopril, indapamide , amlodipine |
| Tripliam | Active comparator | fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily Receives: Drug: Tripliam (perindopril, indapamide, amlodipine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who reach target blood pressure
How many patients have blood pressure within normal limits
Measured: From baseline to the end of the 3-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pelliccia, University of Roma La Sapienza
- Investigators
- Carlo Gaudio, MD, Study chair, Sapienza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710539
- Sponsor's protocol ID
- 124/D/2016
- Acronym
- ONE&ONLY
- Status last verified
- Mar 2016
- First submitted
- 4 Mar 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Marazzi G, Pelliccia F, Campolongo G, Cacciotti L, Massaro R, Poggi S, Tanzilli A, Di Iorio M, Volterrani M, Lainscak M, Rosano GM. Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial. Int J Cardiol. 2016 Nov 1;222:885-887. doi: 10.1016/j.ijcard.2016.07.163. Epub 2016 Jul 29.
PubMed 27522394
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Once-daily Fixed combiNation vErsus freE-drug cOmbination of Three aNtihypertensive Agents in arteriaL hYpertension (the ONE&ONLY Trial)
- ClinicalTrials.gov ID
- NCT02710539
- Acronym / sponsor ID
- ONE&ONLY / 124/D/2016
- Conditions
- Arterial Hypertension
- Keywords
- arterial hypertension, antihypertensive drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 16 Mar 2016 (estimated)
- 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.
Randomized comparison of once-daily fixed combiNation versus free-drug combination of three antihypertensive agents in arterial hypertension
Detailed description
The aim of this randomized study is to compare a once-daily fixed combination pill with a free-drug combination of three antihypertensive agents in arterial hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free combination | Active comparator | Drug: perindopril, indapamide , amlodipinePerindopril 10 mg/daily, indapamide 2,5 mg/daily, and amlodipine 10 mg/daily will be given according to a free combination strategy |
| Tripliam | Active comparator | Drug: Tripliam (perindopril, indapamide, amlodipine)fixed combination of perindopril 10 mg/daily, indapamide 2,5 mg/daily, amlodipine 10 mg/daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with arterial hypertension resistant to monotherapy
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| perindopril, indapamide , amlodipineAlso: Procaptan, Indapamide, NorvascFree combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg | Drug | Free combination |
| Tripliam (perindopril, indapamide, amlodipine)Also: Fixed combination of Procaptan, Indapamide, NorvascFixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg | Drug | Tripliam |
Primary outcome
Number of patients who reach target blood pressure
Time frame: From baseline to the end of the 3-month study period
How many patients have blood pressure within normal limits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Derived from this study: PubMed 27522394Marazzi G, Pelliccia F, Campolongo G, Cacciotti L, Massaro R, Poggi S, Tanzilli A, Di Iorio M, Volterrani M, Lainscak M, Rosano GM. Greater cardiovascular risk reduction with once-daily fixed combination of three antihypertensive agents and statin versus free-drug combination: The ALL-IN-ONE trial. Int J Cardiol. 2016 Nov 1;222:885-887. doi: 10.1016/j.ijcard.2016.07.163. Epub 2016 Jul 29.
- Individual participant dataSharing planned: No
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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.
Carlo Gaudio, MD study chair
Sapienza University
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 perindopril, indapamide , amlodipine and Tripliam (perindopril, indapamide, amlodipine) in people with Arterial Hypertension, run by University of Roma La Sapienza at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pelliccia, MD (+39064997 ext. 123, f.pelliccia@mclink.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who reach target blood pressure (time frame: From baseline to the end of the 3-month study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710539, which also lists 1 linked publication.
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 16 Mar 2016.