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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01089452




Registration number
NCT01089452
Ethics application status
Date submitted
17/03/2010
Date registered
18/03/2010
Date last updated
3/06/2015

Titles & IDs
Public title
Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study
Scientific 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.
Secondary ID [1] 0 0
HREC/10/Alfred/5
Secondary ID [2] 0 0
CP-01/09
Universal Trial Number (UTN)
Trial acronym
ACCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Perindopril
Treatment: Drugs - Perindopril/amlodipine
Treatment: Drugs - Olmesartan/amlodipine

Active comparator: Perindopril monotherapy - Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks

Active comparator: Perindopril/amlodipine - Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.

Experimental: Olmesartan/amlodipine FDC - Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.


Treatment: Drugs: Perindopril
Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks

Treatment: Drugs: Perindopril/amlodipine
Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.

Treatment: Drugs: Olmesartan/amlodipine
Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in blood pressure between the groups
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Absolute cardiovascular risk
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Safety parameters
Timepoint [2] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Over 18 years of age
2. Has provided written informed consent
3. 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.
4. 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)
* 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)
5. Women must be post menopausal or using an acceptable method of contraception i.e. surgical sterilisation, hormonal contraception or double barrier method.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Secondary causes of hypertension (e.g. Conn's Syndrome, renal artery stenosis)
2. Serum creatinine >0.25 mmol/L or eGFR <40 ml/min
3. Serum potassium >5.5 mmol/L
4. Abnormal LFTs (i.e. serum transaminases >2x ULN)
5. Sitting SBP >180 mmHg
6. Recent (<6 months) MI, CVA, TIA, revascularisation procedure
7. Ethanol abuse (in the opinion of the investigator)
8. Concomitant drug therapy that may impact on BP e.g. NSAIDs, COX-2 inhibitors, other antihypertensive agents
9. Unable to comply with study requirements (in the opinion of the investigator)
10. Pregnant or lactating women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Schering-Plough
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT01089452
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Krum, MBBS FRACP PhD
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01089452