Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study
Information source: Monash University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Perindopril (Drug); Perindopril/amlodipine (Drug); Olmesartan/amlodipine (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Monash University Official(s) and/or principal investigator(s): Henry Krum, MBBS FRACP PhD, Principal Investigator, Affiliation: Monash University / Alfred Hospital
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in blood pressure between the groups
Secondary outcome: Absolute cardiovascular riskSafety parameters
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
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
Locations and Contacts
Alfred Hospital, Melbourne, Victoria 3004, Australia
Additional Information
Last updated: June 2, 2015
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