A 12-week, randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy and safety of aliskiren in patients with diabetes and hypertension not adequately responsive to the combination of valsartan 160 mg and hydrochlorothiazide 25 mg.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 336

Inclusion Criteria

1.Outpatients 18 years of age and older.
2.Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide, or an intrauterine device.
3.Patients with a documented diagnosis of either type 1 or type 2 diabetes mellitus. Patients with type 2 diabetes must be on a stable dose of oral antidiabetic therapy medication for at least 4 weeks prior to Visit 1. For type 1 and type 2 diabetic patients requiring insulin therapy adjustment of the dose of insulin is permitted.
4.Patients with hypertension. Non-treated patients must have a MSDBP = 95 mmHg at any Visit 1 and Visit 2; treated patients must have a MSDBP = 85 mmHg at Visit 1 and MSDBP = 95 mmHg at Visit 2.
5.To be eligible for randomization into the double-blind treatment period at Visit 5 (Day 1) all patients must have a MSDBP > 85 mmHg and < 100 mmHg, and a MSSBP < 160 mm Hg.

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

1.Severe hypertension (grade 3 WHO classification; MSDBP >110 mmHg and/or MSSBP >180 mmHg).
2.History or evidence of a secondary form of hypertension.
3.Known Keith-Wagener grade III or IV hypertensive retinopathy.
4.History of hypertensive encephalopathy or cerebrovascular accident.
5.Current diagnosis of heart failure (NYHA Class II-IV).
6.Transient ischemic cerebral attack during the 12 months prior to Visit 1.
7.History of myocardial infarction.
8.History of coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
9.Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L or > 5.2 mEq/L at Visit 1, 3 and 4.
10.Current stable or unstable angina pectoris.
11.Second or third degree heart block without a pacemaker.
12.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
13.Clinically significant valvular heart disease.
14.Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 9.0 % at Visit 1.
15.Any surgical or medical condition or treatment 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.
•Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1.
•Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal 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.
•Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.
•Evidence of renal impairment with an estimated creatinine clearance <50 mL/min according to Cockroft-Gault formula method.
•Current treatment with cholestyramine or colestipol resins.
16.History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
17.History or evidence of drug or alcohol abuse within the last 12 months.
18.Pregnant or nursing women.
19.Known or suspected contraindications to the study medications, including history of allergy to ARBs or thiazide diuretics or other sulfonamide derivatives.
20.Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
21.History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
22.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
23.Participation in any investigational drug trial within one month of Visit 1.
24.Persons directly involved in the execution of this protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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