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Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study (ACCESS)

This study has been terminated.
(Study not started due to administrative reasons.)
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Monash University
ClinicalTrials.gov Identifier:
NCT01089452
First received: March 17, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Perindopril
Drug: Perindopril/amlodipine
Drug: Olmesartan/amlodipine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Monash University:

Primary Outcome Measures:
  • Change in blood pressure between the groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute cardiovascular risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measurements will be performed at baseline and 12 weeks of key variables that contribute to absolute cardiovascular risk.

  • Safety parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Frequency of drug-related adverse events and major cardiovascular events.


Enrollment: 0
Arms Assigned Interventions
Active Comparator: Perindopril monotherapy
Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
 Drug: Perindopril
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.
 Drug: 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.
 Drug: Olmesartan/amlodipine
Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089452

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Monash University
Schering-Plough
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University / Alfred Hospital
  More Information

No publications provided

Responsible Party: Prof Henry Krum, Monash University / Alfred Hospital
ClinicalTrials.gov Identifier: NCT01089452     History of Changes
Other Study ID Numbers: CP-01/09, HREC/10/Alfred/5, 62/10
Study First Received: March 17, 2010
Last Updated: July 20, 2011
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Monash University:
Mild to moderate hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Amlodipine
Olmesartan medoxomil
Perindopril
Olmesartan
Angiotensin Receptor Antagonists
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 21, 2013