Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00171067
Eligibility Criteria:
Inclusion Criteria:
* Patients with mild to moderate hypertension with a mean sitting diastolic blood pressure (MSDBP) \> 85 and \< 110 mmHg for non-treated patients. Previously treated patients with MSDBP \< 110 mmHg. Treated is defined as having taken medication until \< 2 days prior to Visit 1
* Positive urine spot test with Micral dipstick (detection of urinary albumin concentration of at least 50 mg/l) at Visit 1 (day -21).
* Confirmation of MAU of at least 2 out of 3 measurements determined in the first morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day -7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) \> 2.5 mg/mmol and \< 25.0 mg/mmol and for female patients as UACR \> 3.5 mg/mmol and \< 35.0 mg/mmol at both visits.
Exclusion Criteria:
* Evidence of renal impairment as determined by any one of the following:
* serum creatinine clearance \< 30 ml/min as determined by Cockroft and Gault formula \[Cockroft and Gault, 1976\] and/or
* serum creatinine \> 1.25 x ULN at Visit 1,
* a history of dialysis, or
* a history of nephrotic syndrome.
* Serum potassium values \<3.5 mmol/l or \>5.5 mmol/l at Visit 1
* Any medical condition which might significantly alter the urinary excretion of albumin
Other protocol-defined exclusion criteria may apply.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00171067
Study Brief:
Protocol Section:
NCT00171067