A nine-week, randomized, double-blind, parallel group study to evaluate the efficacy and safety of aliskiren 300 mg, compared to irbesartan 300 mg and ramipril 10 mg in the setting of a missed dose in patients with essential hypertensio

Phase 1

• Conditions: Hypertension; MedDRA version: 7.1Classification code 10020772

• Registration Number: EUCTR2005-004993-26-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-16
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

1.Outpatients 18 years of age and older.
2.Patients must meet following blood pressure criteria:
•At Visit 2: Office MSDBP = 90 mmHg and < 110 mmHg
•At Visit 3 (Day -1) : Office MSDBP = 95 mmHg and < 110 mmHg before application of ABPM
•At Visit 3 : 24-hr MADBP = 85 mmHg
3.Patient must have an absolute difference of = 10 mmHg in their office MSDBP between Visit 2 and 3.
4.Male or female patients are eligible. Female patients must be either post-menopausal for at least one year, surgically sterile or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device. Reliable contraception should be maintained throughout the study and for 7 days after study drug discontinuation.
5.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 have 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

1.Severe hypertension [Office MSDBP = 110 mmHg and/or office mean sitting systolic blood pressure (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.Transient ischemic cerebral attack during the 12 months prior to Visit 1.
6.Current diagnosis of heart failure (NYHA Class II-IV).
7.History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1.
8.Current angina pectoris requiring pharmacological therapy.
9.Second or third degree heart block without a pacemaker.
10.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
11.Clinically significant valvular heart disease.
12.History of Type 1 diabetes or history of Type 2 diabetes and glycosylated hemoglobin (HbA1c) > 8 % at Visit 1.
13.Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L or
= 5.5 mEq/L, at Visit 1.
14.Known or suspected contraindications to the study medications, including history of allergy to ACE-Inhibitors or ARBs.
15.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.
•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 as determined by any one of the following: serum creatinine > 1.5 ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
16.Upper arm circumference > 42 cm.
17.Third shift or night workers.
18.History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the past five years.
19.History or evidence of drug or alcohol abuse within the last 12 months.
20.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).
21.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.
22.History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
23.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety.
24.Participation in any investigational drug trial within one month of Visit 1.
25.Persons directly involved in the execution of this protocol.

Study & Design

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