None listed
Conditions
Interventions
Group 1 Type of group
Aliskiren 75 mg od + placebo for 12 weeks
Group name:Group 15 Type of group
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Outpatient patients from 18 years of age. • Both women and men are eligible. Female patients must be postmenopausal for a year, either be surgically sterilized, or use an effective contraceptive method (oral contraceptives, barrier methods with spermicide or intrauterine devices). • Patients with essential hypertension. Patients should have a PADMPS> 90 mmHg and 95 mmHg and <110 mmHg in Visit 3 (day 1). • Patients should have an absolute difference of <10 mmHg in their average diastolic pressure in the sitting position during the last two visits (Visits 2 and 3, or Optional visit 201 and visit 3) of the simple-blind lead-in period of the study. • Patients who are eligible and able to participate in the study, and who give their consent to do so after the purpose and characteristics of the investigation have been clearly explained (written informed consent).
Exclusion criteria
Exclusion criteria: • Patients previously treated with aliskiren • Severe hypertension (grade 3 of the QMS classification, PADMPS> 110 mmHg and / or PASMPS> 180 mmHg). • History or evidence of a secondary hypertension case. • Hypertensive retinopathy known grade m or IV of Keith-Wagener. • History of hypertensive encephalopathy or stroke • Transient cerebral ischemic attack during the 12 months prior to Visit 1. • Current diagnosis of heart failure (NYHA Class II-IV). • History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. • Current angina that requires pharmacological treatment (except sublingual nitroglycerin). • Second or third degree heart block without a pacemaker. • Concurrent arrhythmia or symptomatic arrhythmia that constitute a potential threat to life. • Clinically significant valvular heart disease. • Type 1 or Type 2 diabetes mellitus with inadequate glycemic control, defined as fasting glycosylated hemoglobin (HbAlc)> 9% at Visit 1. • Serum sodium and / or serum potassium below the lower limit of the normal range, dehydration, or hyperkalemia> 5.5 mEq / L in Visit 1. • Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including, but not limited to, any of the following: • History of major surgery of the gastrointestinal tract, such as gastrectomy, • gastroenterostomy, or intestinal resection. • Inflammatory bowel disease currently active or previously active during the 12 months prior to Visit 1. • Gastritis, currently active gastric or duodenal 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, indicated by abnormal values ​​of lipase or amylase. • Evidence of liver disease, determined by any of the following: SGOT or SGPT values ​​exceeding 2 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portocaval anastomosis. • Evidence of renal failure, determined by any of the following: serum creatinine> 1.5 x ULN at Visit 1, history of dialysis, or history of nephrotic syndrome. • History of malignant disease, including leukemia and lymphoma (but non-basal cell skin cancer) within the last five years. • History or evidence of drug or alcohol abuse within the past 12 months. • Pregnant or lactating women. • Any medical or surgical condition that, in the opinion of the investigator, may put the patient at greater risk for participating in the study, or that may prevent the patient from meeting the requirements or completing the study. • Known or suspected contraindications to study medications, including history of allergy to angiotensin receptor blockers and / or diuretic-diazidic drugs or other drugs derived from sulfonamide. • History of gouty arthritis. • History of non-adherence to medical regimens, or unwillingness to comply with the study protocol. • Any condition that, in the opinion of the researcher or Novartis clinical monitor, could compromise the evaluation of efficacy or safety. • Participation in any trial with an experimental drug within 1 month before Visit 1. • People with direct participation in the execution of this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:change from the baseline (Visit 3) in the mean diastolic blood pressure in the sitting position. Measure:Diastolic blood pressure Timepoints:At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Change from baseline (Visit 3) in mean systolic blood pressure in sitting position Measure:Mean systolic blood pressure in sitting position Timepoints:in weeks 4, 8 and at the end point ; Outcome name:A first-order response surface analysis will be performed, with the dose as a predictive variable and using the 15 treatments, to study the change in mean diastolic blood pressure in the sitting position at the end point with respect to the baseline. Measure:Surface analysis of dose response Timepoints:at the end point ; Outcome name:The proportion of patients, in each treatment, that achieves a response in the mean diastolic blood pressure in the sitting position during the double-blind period will be compared at the end point Measure:Responders Analysis Timepoints:at the end point, week 4 and week 8 ; Outcome name:changes from baseline in diastolic and systolic blood pressure in standing position Measure:changes from baseline in diastolic and systolic blood pressure in standing position Timepoints:in week 8 and at the end point | — |
Outcome results
None listed