A twelve week, randomized, double-blind, parallel-group multicentre study to evaluate the efficacy and safety of the combination of aliskiren/ramipril/amlodipine (300/10/10mg), compared to the combinations of ramipril/amlodipine (10/10mg) and aliskiren/amlodipine (300/10mg) in patients with essential hypertension and metabolic syndrome not adequately responsive to amlodipine 10mg. - N.A.

• Conditions: patients with essential hypertension and metabolic syndrome.

• Registration Number: EUCTR2007-003677-10-GB
• Lead Sponsor: ovartis Pharmaceuticals UK Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Outpatients 18-70 years of age and older.
2.Male or female patients are eligible.
3.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 MSBBP = 140 mmHg and < 180 mmHg at Visit 1.
•Patients treated with antihypertensive monotherapy medications must have a MSSBP = 130 mmHg and < 180 mmHg at Visit 1.
•Patients taking amlodipine monotherarpy with a MSSBP = 130 mmHg and < 180. For patients taking amlodipine 5mg visits 1 and 2 can be combined and for patients taking amlodipine 10mg visits 1 and 3 can be combined (vist 2 not necessary).
4.All patients must have a MSSBP = 140 mmHg and < 180 mmHg at Visit 3, the end of the amlodipine run-in period.
5.Patients with a diagnosis of Metabolic Syndrome (Definition of International Diabetes Federation – IDF 2006)
- Central obesity - waist circumference (cm)
South Asian / Chinese / Japanese / Central+South American =90cm ?, = 80cm ?
Europid / Subsaharan African / Middle East =94cm ? , =80cm ?
and 1 of
- Fasting plasma glucose of =5.6mmol/l
- Triglycerides = 1.7 mmol/l (or on therapy)
- HDL cholesterol < 1.03 mmol/l males, < 1.29 mmol/l females (or on therapy)
6.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 informed consent).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with any of the following at Visit 1, Visit 2, Visit 3 (unless otherwise stated) will be excluded from participation in the study.
1.Previously treated in an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period.
2.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (= 5 mIU/ml).
3.Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception (implantable, patch, oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
4.Patients currently on antihypertensive medication(s) that require tapering of > 7 days at Visit 1.
5.Severe hypertension (an office cuff MSDBP = 115 mmHg and/or MSSBP = 180 mmHg).
6.History or evidence of a secondary form of hypertension.
7.Known Keith-Wagener grade III or IV hypertensive retinopathy.
8.Previous or current diagnosis of heart failure (NYHA Class II-IV).
9.History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
10.Serum sodium < 135 mEq/ L (mmol/L) at Visit 1, if confirmed on repeat sample.
11.Serum potassium < 3.5 mEq/L (mmol/L) or = 5.3 mEq/L (mmol/L) at Visit 1, if confirmed on repeat sample.
12.Type 1 diabetes mellitus.
13.Type 2 diabetes mellitus if change in oral hypoglycaemic in previous 3 months..
14.Current angina pectoris requiring pharmacological therapy.
15.Second or third degree heart block without a pacemaker.
16.Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1.
17.Clinically significant valvular heart disease.
18.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
•History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
•History of active inflammatory bowel disease during the 12 months prior to Visit 1.
•Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal bleeding during the 3 months prior to Visit 1.
•Any history of pancreatic injury, pancreatitis, or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase during the 12 months prior to Visit 1.
•Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified