HypertensionPhase 4ACCESSNCT01089452
Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study
A Phase 4 study testing Perindopril, Perindopril/amlodipine and Olmesartan/amlodipine in people with Hypertension, run by Monash University at 1 site in Australia.
Trial summary
This study is looking to evaluate which drug combination, olmesartan/amlodipine or perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Perindopril, Perindopril/amlodipine and Olmesartan/amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Start not givento not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Has provided written informed consent
- Mild to moderate hypertension (WHO Stage 1-2). Patients with mild to moderate hypertension will be either de novo presenters with this condition or withdrawn from background antihypertensive therapy for a period of 2 weeks. If sSBP is not greater than 140 mmHg after this 2 week withdrawal period (*130 mmHg if diabetes or CKD, as per Heart Foundation of Australia Hypertension Guidelines 20082), patients can be followed, off therapy, for a further 2 weeks in order to meet this criterion. If their systolic blood pressure is above 180 mmHg they will be withdrawn from the study and will be provided with appropriate treatment.
- Hypertensive patients with a high level of risk, i.e. having at least one of the following risk factors :
- History of CV event eg MI, stroke (>6 months ago)
- History of revascularization procedure (>6 months ago)
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- Impaired kidney function (eGFR <70 ml/min)
- ECG or echocardiographic evidence of LV hypertrophy
- Obesity, defined as BMI >30 kg/m2
- Diabetes mellitus
- Peripheral arterial disease
- Macroalbuminuria
- Current smoking (defined as smoking at least 7 cigarettes per week)
- Women must be post menopausal or using an acceptable method of contraception i.e. surgical sterilisation, hormonal contraception or double barrier method.
Who cannot join
- Secondary causes of hypertension (e.g. Conn's Syndrome, renal artery stenosis)
- Serum creatinine >0.25 mmol/L or eGFR <40 ml/min
- Serum potassium >5.5 mmol/L
- Abnormal LFTs (i.e. serum transaminases >2x ULN)
- Sitting SBP >180 mmHg
- Recent (<6 months) MI, CVA, TIA, revascularisation procedure
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- Ethanol abuse (in the opinion of the investigator)
- Concomitant drug therapy that may impact on BP e.g. NSAIDs, COX-2 inhibitors, other antihypertensive agents
- Unable to comply with study requirements (in the opinion of the investigator)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ACCESS STUDY (Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study) ARB/CCB Combination Therapy: Efficacy vs an ACE-inhibitor/CCB Combination and Use as First Line Therapy.
This study is looking to evaluate which drug combination, olmesartan/amlodipine or perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate hypertension. The investigators will be enrolling people who are either currently taking medication to lower their blood pressure or who have been recently diagnosed with high blood pressure and are not yet on medication.
Patients on medication for their blood pressure will be asked to stop taking this medication for 2 to 4 weeks. If their blood pressure is suitable (not too high or low) they will be randomised to one of their treatment arm:
Read more
Group 1 will receive Perindopril on its own (5mg for 4 weeks followed by 10mg for 8 weeks). There will be 80 patients in this group.
Group 2 will receive Perindopril and Amlodipine together (5mg/5mg for 4 weeks, 10mg/5mg for a further 4 weeks then 10mg/10mg for the final 4 weeks). There will be 80 patient in this group.
Group 3 will receive Olmesartan and Amlodipine together (20mg/5mg for 4 weeks, 40mg/5mg for a further 4 weeks then 40mg/10mg for the final 4 weeks). There will be 120 patients in this group.
During the study we will measure the patients blood pressure and heart rate, weight and perform routine blood tests. They will also have ECGs (3 occasions) and 24 hour blood pressure monitor (4 occasions).
At the end of the study patients pre-study medication will be restarted or they will be put on to a suitable alternative.
- Conditions
- Hypertension
- Being tested
- Perindopril, Perindopril/amlodipine, Olmesartan/amlodipine
- Keywords
- Mild to moderate hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerindoprilDrug
Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
Perindopril/amlodipineDrug
Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.
Olmesartan/amlodipineDrug
Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.
| Study group | Role | What they receive |
|---|---|---|
| Perindopril monotherapy | Active comparator | Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks Receives: Drug: Perindopril |
| Perindopril/amlodipine | Active comparator | Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration. Receives: Drug: Perindopril/amlodipine |
| Olmesartan/amlodipine FDC | Experimental | Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration. Receives: Drug: Olmesartan/amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure between the groups
Measured: 12 weeks
Secondary outcomes (2)
Absolute cardiovascular risk
Measurements will be performed at baseline and 12 weeks of key variables that contribute to absolute cardiovascular risk.
Measured: 12 weeks
Safety parameters
Frequency of drug-related adverse events and major cardiovascular events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
Why it stopped: Study not started due to administrative reasons.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Investigators
- Henry Krum, MBBS FRACP PhD, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089452
- Sponsor's protocol ID
- CP-01/09
- Other IDs
- HREC/10/Alfred/5, 62/10
- Acronym
- ACCESS
- Status last verified
- Jun 2015
- First submitted
- 17 Mar 2010
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS STUDY (Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study) ARB/CCB Combination Therapy: Efficacy vs an ACE-inhibitor/CCB Combination and Use as First Line Therapy.
- ClinicalTrials.gov ID
- NCT01089452
- Acronym / sponsor ID
- ACCESS / CP-01/09
- Conditions
- Hypertension
- Keywords
- Mild to moderate hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started due to administrative reasons.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Schering-Plough
- First posted
- 18 Mar 2010 (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.
This study is looking to evaluate which drug combination, olmesartan/amlodipine or perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate hypertension. The investigators will be enrolling people who are either currently taking medication to lower their blood pressure or who have been recently diagnosed with high blood pressure and are not yet on medication.
Patients on medication for their blood pressure will be asked to stop taking this medication for 2 to 4 weeks. If their blood pressure is suitable (not too high or low) they will be randomised to one of their treatment arm:
Group 1 will receive Perindopril on its own (5mg for 4 weeks followed by 10mg for 8 weeks). There will be 80 patients in this group.
Group 2 will receive Perindopril and Amlodipine together (5mg/5mg for 4 weeks, 10mg/5mg for a further 4 weeks then 10mg/10mg for the final 4 weeks). There will be 80 patient in this group.
Group 3 will receive Olmesartan and Amlodipine together (20mg/5mg for 4 weeks, 40mg/5mg for a further 4 weeks then 40mg/10mg for the final 4 weeks). There will be 120 patients in this group.
During the study we will measure the patients blood pressure and heart rate, weight and perform routine blood tests. They will also have ECGs (3 occasions) and 24 hour blood pressure monitor (4 occasions).
At the end of the study patients pre-study medication will be restarted or they will be put on to a suitable alternative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perindopril monotherapy | Active comparator | Drug: PerindoprilPerindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks |
| Perindopril/amlodipine | Active comparator | Drug: Perindopril/amlodipinePerindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration. |
| Olmesartan/amlodipine FDC | Experimental | Drug: Olmesartan/amlodipineOlmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Over 18 years of age
- Has provided written informed consent
- Mild to moderate hypertension (WHO Stage 1-2). Patients with mild to moderate hypertension will be either de novo presenters with this condition or withdrawn from background antihypertensive therapy for a period of 2 weeks. If sSBP is not greater than 140 mmHg after this 2 week withdrawal period (*130 mmHg if diabetes or CKD, as per Heart Foundation of Australia Hypertension Guidelines 20082), patients can be followed, off therapy, for a further 2 weeks in order to meet this criterion. If their systolic blood pressure is above 180 mmHg they will be withdrawn from the study and will be provided with appropriate treatment.
- Hypertensive patients with a high level of risk, i.e. having at least one of the following risk factors :
- Women must be post menopausal or using an acceptable method of contraception i.e. surgical sterilisation, hormonal contraception or double barrier method.
Key exclusion criteria (10 listed)
- Secondary causes of hypertension (e.g. Conn's Syndrome, renal artery stenosis)
- Serum creatinine >0.25 mmol/L or eGFR <40 ml/min
- Serum potassium >5.5 mmol/L
- Abnormal LFTs (i.e. serum transaminases >2x ULN)
- Sitting SBP >180 mmHg
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 |
|---|---|---|
| PerindoprilPerindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks | Drug | Perindopril monotherapy |
| Perindopril/amlodipinePerindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration. | Drug | Perindopril/amlodipine |
| Olmesartan/amlodipineOlmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration. | Drug | Olmesartan/amlodipine FDC |
Primary outcome
Change in blood pressure between the groups
Time frame: 12 weeks
2 secondary outcomes
Absolute cardiovascular risk
Time frame: 12 weeks
Safety parameters
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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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.
Henry Krum, MBBS FRACP PhD principal investigator
Monash University / Alfred Hospital
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, Perindopril/amlodipine and Olmesartan/amlodipine in people with Hypertension, run by Monash University at 1 site in Australia.
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 14 inclusion and 10 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: withdrawn, as of the sponsor's last update on 3 Jun 2015. 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 Australia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in blood pressure between the groups (time frame: 12 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 3 Jun 2015.