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

NCT ID: NCT01089452

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Perindopril monotherapy

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

Group Type: ACTIVE_COMPARATOR

Perindopril

Intervention Type: DRUG

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

Perindopril/amlodipine

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

Group Type: ACTIVE_COMPARATOR

Perindopril/amlodipine

Intervention Type: DRUG

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

Olmesartan/amlodipine FDC

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

Group Type: EXPERIMENTAL

Olmesartan/amlodipine

Intervention Type: DRUG

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

Interventions

Perindopril

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

Intervention Type: DRUG

Perindopril/amlodipine

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

Intervention Type: DRUG

Olmesartan/amlodipine

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Monash University / Alfred Hospital

Principal Investigators

Henry Krum, MBBS FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University / Alfred Hospital

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

HREC/10/Alfred/5

Identifier Type: OTHER

Identifier Source: secondary_id

62/10

Identifier Type: OTHER

Identifier Source: secondary_id

CP-01/09

Identifier Type: -

Identifier Source: org_study_id