Clinical trial NCT00542269: Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome
Official title: A Twelve Week, Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren/Ramipril/Amlodipine (300/10/5-10 mg) Compared to the Combinations of Ramipril/Amlodipine (10/5-10 mg) and Aliskiren/Amlodipine (300/5-10 mg) in Patients With Essential Hypertension and Metabolic Syndrome Not Adequately Responsive to Amlodipine 5-10 mg
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension With Metabolic Syndrome
Keywords: Hypertension
Metabolic Syndrome
Dual combination therapy
Triple combination therapy
Aliskiren
Direct Renin inhibitor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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 applied to the study.

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine)
timeFrame: Baseline to Week 12
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine
timeFrame: Baseline to Week 12
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine
timeFrame: Baseline to Week 12
measure: Percentage of Patients Who Achieved Normalized Blood Pressure at End of Study
timeFrame: Week 12
measure: Change in HOMA-IR From Baseline to End of Study
timeFrame: Baseline to Week 12
measure: Change in HOMA-β From Baseline to End of Study
timeFrame: Baseline to Week 12
measure: Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Ramipril/Amlodipine vs Ramipril/Amlodipine
timeFrame: Baseline to Week 12
measure: Change in HbA1c (Glycated Hemoglobin) From Baseline to End of Study - Aliskiren/Amlodipine vs Ramipril/Amlodipine)
timeFrame: Baseline to Week 12
measure: Percentage of Patients Who Developed Diabetes at End of Study
timeFrame: Week 12
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Novartis Great Britian
name: Novartis
role: STUDY_CHAIR
References: