None listed
Conditions
Interventions
Intervention1: Aliskiren: 300mg/day for 4 weeks
Control Intervention1: Placebo: 4 weeks
Sponsors
Novartis Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female out-Subjects aged 18 to 65 years. 2. Subjects with a diagnosis of mild to moderate essential hypertension: Subjects who are newly diagnosed with hypertension or Subjects who have not received anti-hypertensive medication for at least 2 weeks prior to Visit 1 have to have a mean sitting diastolic blood pressure (msDBP) &#8805; 95 and < 110 mmHg and mean sitting systolic blood pressure (msSBP) < 180 mmHg at Visit 1/Visit 3 and at Visit 6. ? Subjects with history of hypertension and on current antihypertensive medication at Visit 1 have to have a msDBP < 110 mmHg at Visit 1 and a msDBP &#8805; 95 and < 110 mmHg and a msSBP < 180 mm Hg at Visit 3 and at Visit 6. 3. Female Subjects must be of non-child bearing potential defined as postmenopausal females with no regular menstrual bleeding for at least 1 year prior to inclusion (Menopause will be confirmed by a plasma FSH level of >40 IU/L), OR female subjects surgically sterilized at least 6 months prior to screening (Surgical Sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF). All female subjects must have negative pregnancy results at screening and baseline Day -2 (regardless of reported reproductive status). 4. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2. See Appendix 3 of this protocol for BMI ranges. 5. Mild smokers (use of less than 10 cigarettes or beedies per day) will be allowed participation, provided they are willing to discontinue during the PK/PD sampling in the trial. 6. Subjects who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
Exclusion criteria
Exclusion criteria: Severe hypertension (msDBP &#8805; 110 mmHg and/or msSBP &#8805; 180 mmHg) History or evidence of a secondary form of hypertension [renal, endocrine origin, etc.] Inability to discontinue all prior anti-hypertensive medications safely before placebo runin period History of severe hypersensitivity or contraindications to study drug or a drugs belonging to the similar therapeutic class (ARB, Angiotensin-converting-enzyme inhibitor (ACEs), aliskiren) as the study drug, including a history of angioedema. Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or plasma up to 7 days prior to randomization. Use of other investigational drugs at the time of enrollment (Visit 1), or within 30 days or 5 half-lives of enrollment, whichever is longer. History of immunodeficiency diseases, including a positive HIV (As per local guidance). A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (As per local guidance). Any surgical or medical condition which in the opinion of the investigator may place the Subject at higher risk from his/her participation in the study, or is likely to prevent the Subject from complying with the requirements of the study or completing the study. History of noncompliance to medical regimens or unwillingness to comply with the study protocol. Subjects who have been previously (within 3 months of Visit 1) been treated with aliskiren Nursing (lactating) women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of light meals on the pharmacokinetics and pharmacodynamics (PRA) of the study drugTimepoint: Nil | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability following multiple oral doses of the 300 mg market tablet in Subjects with mild to moderate essential hypertension.Timepoint: Nil | — |
Countries
India
Contacts
Public ContactRajesh Karan
Novartis Healthcare Pvt. Ltd.
Outcome results
None listed