None listed
Conditions
Interventions
Group 1 Type of group
Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was adde
Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additi
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Outpatients male or female> 18 years of age. • Patients with essential hypertension: Patients without prior exposure to treatment should have a PSSSM> 150 mm Hg and 150 mm Hg and <180 mm Hg at Visit 2. • Informed written consent to participate in this study before any study procedure.
Exclusion criteria
Exclusion criteria: • Patients who have been previously treated in an aliskiren study that has contained the aliskiren and amiodipine combination treatment group and who have been randomly assigned or recruited in the active drug treatment period of that study. • Severe hypertension (PSDSM ^ 110 mm Hg and / or PSSSM> 180 mm Hg). • Pregnant or breastfeeding (nursing) women, where pregnancy is defined as the status of a woman after conception and until termination of pregnancy, confirmed by a 5 hU / mL positive hCG laboratory test. • Women with the potential for pregnancy (WOCBP), defined as all women who are physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation rules out having sex with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two methods of birth control. The two methods may be a double barrier (if accepted by local Ethics Committees) or a barrier method plus a hormonal method. • History or evidence of a form of secondary hypertension. • Keith-Wagener hypertensive retinopathy grade III or IV known. • Any history of hypertensive encephalopathy or stroke, or history within 12 months of Visit 1 of transient ischemic stroke (AIT), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). • Previous or current diagnosis of heart failure (NYHA Class II-IV). • Serum potassium> 5.5 mEq / L (mmol / L) in Visit 1. • Patients with Type 1 or Type 2 diabetes mellitus that are not well controlled, based on the clinical judgment of the investigator. Patients with diabetes mellitus recruited in this study should be well controlled. It is recommended that patients currently being treated for diabetes mellitus be at a stable dose of the antidiabetic drug for at least 4 weeks before Visit 1. • Current angina pectoris that requires drug therapy except nitrates. • Second or third degree heart block without a pacemaker. • Atrial fibrillation or atrial flutter at Visit 1 or life-threatening arrhythmia during the 12 months prior to Visit 1. • Clinically symptomatic valvular heart disease at Visit 1. • Any medication, surgical or medical condition, that can significantly alter the absorption, distribution, metabolism or excretion of medications • Gouty arthritis • Known or suspected contraindications, including a history of allergy or hypersensitivity to renin inhibitors, calcium channel blockers, thiazide diuretics or other drugs with similar chemical structures. • History of malignancy of some organ system, treated or not treated, within the last 5 years, with evidence or not of local recurrence or metastasis, with the exception of localized basal cell skin carcinoma. • History or evidence of drug or alcohol abuse during the past 12 months. • Any surgical or medical condition that, in the opinion of the researcher, may place the patient at a greater risk due to his participation in the study, or if it is likely to prevent the patient from complying with the requirements of the study or completing the study. • Use of other investigational medications at the time of recruitment, or within 30 days or 5 half-lives of recruitment, whichever is longer. • If the patient is expected to continue or start with any medication listed in Section 6.5.7 Concomitant medications. • History of non-compliance with medical regimes or lack of wil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate. Measure:Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks Timepoints:Baseline, 8 weeks, 16 weeks, and 24 weeks ; Outcome name:Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate. Measure:Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24 Timepoints:Baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate. Measure:Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32 Timepoints:Baseline to 32 weeks ; Outcome name:Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate. Measure:Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks Timepoints:Baseline, 8 weeks, 16 weeks and 24 weeks ; Outcome name:Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate. Measure:Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24 Timepoints:Baseline to 24 weeks ; Outcome name:Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood | — |
Countries
Canada, Costa Rica, France, Germany, Greece, Guatemala, Peru, South Africa, Switzerland, United Kindgdom, Venezuela
Contacts
Public ContactJose Carlos Veliz
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed