Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertensio
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-097-08
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
• Male or female outpatients 18 years of age or older.
• Patients should have a PADMPS> 90 mmHg and <110 mmHg in the visit before Visit 3 (Visit 2 or Optional visit 201).
• Patients must have a PADMPS> 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).
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method