None listed
Conditions
Interventions
Group 1 Type of group
Placebo. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study
Group 9 Type of group
Aliskiren/amlodipine 300/10 mg tablet. 300/5 for 1 week, then up-titrated to 300/10 mg. Each dose was to be taken orally with water at approximately 8:00 A.M., except on the morning of the next office/clinic visit, when the study medication was to be taken at the site after the visit procedures were completed. In order to adequately blind the study, patients were required to take a total of 4 tablets and 1 capsule of study medication throughout the study
4 of the 5 pills taken were placebos.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Male or female outpatients 18 years of age or older. • Patients should have a PADMPS> 90 mmHg and 95 mmHg and <110 mmHg at Visit 3 (Day 1 / randomization). • All patients should have an absolute difference of <10 mmHg in their PADMPS during the last 2 visits of the single blind treatment period (Visit 2 and 3 or Visits 201 and 3). • Patients who are eligible, able to participate in the study and who consent to do so after the purpose and nature of the investigation have been clearly explained (written informed consent).
Exclusion criteria
Exclusion criteria: • Patients who have been previously treated in an aliskiren study that has been contained in the aliskiren and amlodipine combination treatment group and that have been randomly assigned or recruited during the active drug treatment period of that study. • Severe hypertension (PADMPS> 110 mmHg and / or PASMPS> 180 mmHg). • Women who are pregnant or nursing (lactating), where pregnancy is defined as a woman´s state after conception and until the end of pregnancy, confirmed by a positive hCG laboratory test (s 5 mlU / ml) . • Women with the potential to have children (MRE), defined as all women physiologically able to get pregnant, including women whose career, lifestyle, or sexual orientation rule out having sex with a male partner and women whose partners they have been sterilized by vasectomy or other means, UNLESS they are using two methods of birth control. The two methods can 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. • Kelth-Wagener hypertensive retinopathy grade 111 or IV known. • Any history of hypertensive encephalopathy or stroke, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI). • Previous or current diagnosis of heart failure (NYHA Class II-IV). • Serum potassium> 5.3 mEq / L (mmol / L) at visit 1. • Patient with diabetes mellitus type 1 or type 2 whose hemoglobin glycosylated (HbA1c) is> 8% at visit 1. • Angina of the chest that requires pharmacological therapy (the use of nitrates will be allowed for the treatment of angina). • Second or third degree ventricular atrial block without a pacemaker or arrhythmia that is potentially life threatening during the 12 months prior to the visit 1. • Clinically symptomatic valve disease at Visit 1. • Any medication, surgical or medical condition, that can significantly alter the absorption, distribution, metabolism or excretion of medications. • Known or suspected contraindications, including history of allergy or hypersensitivity to renin inhibitors, calcium channel blockers or other drugs with similar chemical structures. • History of malignancy of any organ system, treated or untreated, within the last 5 years, whether or not there is evidence 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 investigator, may place the patient at greater risk due to participation in the study, or if it is likely to prevent the patient from meeting the requirements of the study or completing e. study. • Use of other investigational drugs at the time of recruitment, or within 30 days or 5 half-lives of the 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 regimens or lack of will to comply with the study protocol. • Any condition that, in the opinion of the researcher or the Novartis Medical Monitor, could confuse the evaluation and interpretation of efficacy and / or safety data. • People directly involved in the execution of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. Measure:Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Aliskiren 300 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) Timepoints:Baseline to end of study (Week 8) ; Outcome name:The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. Measure:Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Diastolic Blood Pressure (msDBP) Timepoints:Baseline to end of study (Week 8) ; Outcome name:The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, diastolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. Measure:Pairwise Comparison of Aliskiren/Amlodipine 300/5 mg vs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The arm in which the highest sitting systolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. Measure:Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Aliskiren 150 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) Timepoints:Baseline to end of study (Week 8) ; Outcome name:The arm in which the highest sitting systolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. Measure:Pairwise Comparison of Aliskiren/Amlodipine 150/5 mg vs. Amlodipine 5 mg on Change in Mean Sitting Systolic Blood Pressure (msSBP) Timepoints:Baseline to end of study (Week 8) ; Outcome name:The arm in which the highest sitting systolic pressures were found at study entry was the arm used for all subsequent readings. An automated BP measurement device and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic BP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. Measure:Pairwise Comparison of Aliskire | — |
Countries
Argentina, Australia, Canada, Colombia, Denmark, Dominican Republic, Finland, Greece, Italy, Panama, Romania, Russian Federation, South Africa, Spain, Sweden, Taiwan, United States
Contacts
Public ContactPatricia Acosta
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed