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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00542269

Purpose

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.

Condition	Intervention	Phase
Hypertension With Metabolic Syndrome	Drug: ramipril/amlodipine (10/10 mg) Drug: aliskiren/amlodipine (300/10 mg) Drug: aliskiren/ramipril/amlodipine (300/10/10mg)	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Ramipril Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Reduction in msSBP from baseline to 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in HbA1c levels from baseline [ Time Frame: end of study ] [ Designated as safety issue: No ]
Onset of diabetes during the study. [ Time Frame: end of study ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	846
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental aliskiren/ramipril/amlodipine (300/10/10mg)	Drug: aliskiren/ramipril/amlodipine (300/10/10mg) aliskiren/ramipril/amlodipine (300/10/10mg)
2: Active Comparator ramipril/amlodipine (10/10 mg)	Drug: ramipril/amlodipine (10/10 mg) ramipril/amlodipine
3: Experimental aliskiren/amlodipine (300/10 mg)	Drug: aliskiren/amlodipine (300/10 mg) aliskiren/amlodipine (300/10 mg)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542269

Contacts

Contact: Novartis

+41 61 324 1111

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

Novartis Great Britian

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CSPP100AGB01
Study First Received:	October 9, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00542269
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

Hypertension
Metabolic Syndrome
Dual combination therapy

Triple combination therapy
Aliskiren
Direct Renin inhibitor

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension

Ramipril
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Disease
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Membrane Transport Modulators
Pathologic Processes
Syndrome
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009