A clinical trial to study the effect of light meal on Aliskiren (300mg) in patients with high blood pressure

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2009
INTERVENTION: Intervention1: Aliskiren: 300mg/day for 4 weeks Control Intervention1: Placebo: 4 weeks CONDITION: Mild to moderate hypertensive patients PRIMARY OUTCOME: To evaluate the effect of light meals on the pharmacokinetics and pharmacodynamics (PRA) of the study drug‐‐‐‐‐‐Timepoint: Nil SECONDARY OUTCOME: 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 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) ≥ 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 ≥ 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 sur
Epistemonikos ID: f5bcc1022f9cf226a710162cd09d1268fb88df12
First added on: Aug 22, 2024