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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT00274118
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects between the ages 35 and 80 years.
2. Current ACE inhibitor therapy for a minimum period of 3 months prior to study entry.
3. Confirmed diagnosis of type II diabetes:
* Subjects currently treated by diet or diet and oral hypoglycaemic drugs, OR
* Subjects currently treated with insulin, with a history of onset of diabetes after the age of 40 and a body weight in excess of ideal body weight at the time of diagnosis, and treated with oral agents for a minimum period of two years
4. On treatment diastolic blood pressure of \< 95 mmHg.
5. Documentation of a normal renal ultrasound within previous 6 months prior to inclusion (alternate methods eg pyelography, renal isotope method was also acceptable).
6. Mean of three consecutive overnight urinary albumin excretion rates \> 20 and \< 1000 g/min at the end of the pre-treatment observation period. (A minimum of two of the three samples must be \> 20 g/min.)
7. Glycosylated haemoglobin (HbA 1c) \< 10%.
8. Serum creatinine \< 140 mol/L.
9. Glomerular filtration rate (GFR) \> 70 ml/min/1.73 m2.
10. Ability to provide written informed consent.
Exclusion Criteria:
1. Type I diabetes mellitus.
2. Pre-menopausal women (last menstruation \< 1 year prior to start of screening period):
* Who were not surgically sterile (tubal ligation, hysterectomy) or
* Who were not practising acceptable means of birth control (and do not plan to continue using this method throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives.
* Who had a positive serum pregnancy test at baseline.
3. Afro-Caribbean subjects.
4. Mean seated SBP \> 180 mmHg.
5. Hepatic dysfunction as defined by the following laboratory parameters: SGPT(ALT) or SGOT(AST) \> 1.5 times the upper limit of normal.
6. Known causes of renal dysfunction other than diabetic nephropathy.
7. Subjects who had a solitary kidney or known renal artery stenosis.
8. NYHA functional class CHF II - IV.
9. Known drug or alcohol dependency.
10. Subjects receiving any investigational therapy within one month of providing written informed consent.
11. Known hypersensitivity to telmisartan or ACE inhibitors or to any component of the formulation.
12. Subjects with a history of suspected angioedema related to ACE inhibitor therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT00274118
Study Brief:
Protocol Section:
NCT00274118