Efficacy and Safety of Aliskiren +/- Ramipril When Added to Amlodipine in Hypertensive Patients With Metabolic Syndrome

Condition(s) targeted: Hypertension With Metabolic Syndrome

Intervention: ramipril/amlodipine (10/10 mg) (Drug); aliskiren/amlodipine (300/10 mg) (Drug); aliskiren/ramipril/amlodipine (300/10/10mg) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis Great Britian

Overall contact:
Novartis, Phone: +41 61 324 1111

This proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy.

Official title: A Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Ramipril/Amlodipine (300/10/10mg) Compared to the Combinations of Ramipril/Amlodipine (10/10 mg) and Aliskiren/Amlodipine (300/10 mg) in Patients With Essential Hypertension and Metabolic Syndrome Not Adequately Responsive to Amlodipine 10 mg.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Reduction in msSBP from baseline to 12 weeks.

Reduction in msSBP from baseline to 12 weeks.

Secondary outcome:

Change in HbA1c levels from baseline

Onset of diabetes during the study.

To evaluate the safety and tolerability profile of all treatment groups including the development of ankle swelling.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients 18-75 years of age.

- Male or female patients are eligible.

- Patients with a diagnosis of hypertension:

- Newly diagnosed patients or patients who have not been treated for hypertension within

the 4 weeks prior to Visit 1 must have a mean sitting systolic blood pressure (MSSBP) > 150 mmHg and < 180 mmHg at Visit 1.

- Patients treated with antihypertensive monotherapy must have a MSSBP ≥ 140 mmHg and

<180 mmHg at Visit 1.

- Patients taking amlodipine monotherapy MSSBP > 140 mmHg and < 180 mmHg at visit 1.

- All patients must have a MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 3, the end of the

amlodipine run-in period.

- Metabolic syndrome

- Patients who are eligible and able to participate in the study, and who consent to do

so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form).

Exclusion Criteria:

- Severe hypertension (office cuff MSDBP ≥ 115 mmHg and/or MSSBP ≥ 180 mmHg).

- History or evidence of a secondary form of hypertension.

- History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic

cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).

- Serum sodium < 135 mmol/L at Visit 1 if confirmed on repeat sample.

- Serum potassium < 3. 5 mmol/L or ≥ 5. 3 mmol/L at Visit 1, if confirmed on repeat

sample

- Type 1 diabetes mellitus

- Type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication

change) in previous 3 months

- Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis, Phone: +41 61 324 1111

Addenbrookes Hospital, Cambridge, United Kingdom; Recruiting
Novartis, Phone: +41 61 324 1111

Starting date: March 2008
Ending date: March 2010
Last updated: January 7, 2009