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.”

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.

Study Type: Interventional

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

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: ramipril/amlodipine (10/10 mg)
  • ramipril/amlodipine
• Drug: aliskiren/amlodipine (300/10 mg)
  • aliskiren/amlodipine (300/10 mg)
• Drug: aliskiren/ramipril/amlodipine (300/10/10mg)
  • aliskiren/ramipril/amlodipine (300/10/10mg)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • aliskiren/ramipril/amlodipine (300/10/10mg)
• Active Comparator: 2
  • ramipril/amlodipine (10/10 mg)
• Experimental: 3
  • aliskiren/amlodipine (300/10 mg)

Primary Measures

• Reduction in msSBP from baseline to 12 weeks.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Reduction in msSBP from baseline to 12 weeks.
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Change in HbA1c levels from baseline
  • Time Frame: end of study
    Safety Issue?: No
• Onset of diabetes during the study.
  • Time Frame: end of study
    Safety Issue?: No
• To evaluate the safety and tolerability profile of all treatment groups including the development of ankle swelling.
  • Time Frame: end of study
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Chair Novartis Great Britian  

Overall Contact: Novartis +41 61 324 1111 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542269

Study ID Number: CSPP100AGB01

ClinicalTrials.gov Identifier: NCT00542269

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency