A randomized, double blind, active controlled, parallel group study to evaluate the effectiveness of valsartan 320 mg in combination with lisinopril 20 mg versus monotherapy with lisinopril 40 mg or valsartan 320 mg in hypertensive patients with microalbuminuria on reduction of urinary albumin creatinine ratio. - Valeria
- Conditions
- Adult patient with mild to moderate essential hypertension and microalbuminuria.MedDRA version: M15Level: LLTClassification code 10020772
- Registration Number
- EUCTR2004-000186-35-HU
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
• Male or female subjects, age between 18-75 years inclusive.
• Patients with mild to moderate hypertension with a MSDBP >= 85 and < 110 mm Hg for non treated patients. Previously treated patients with MSDBP < 110 mm Hg. 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 >= 20 mg/l) at Visit 1 (day -21).
• Written informed consent to participate in the study prior to any study procedures.
• Confirmation of MAU determined in the first morning urine samples performed at Visit 2 (day -14) and Visit 3 (day -7). MAU is defined for male patients as 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.
• At Visit 4 all patients with mild to moderate hypertension with a MSDBP >= 85 mm Hg and < 110 mm Hg.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Any kind of kidney disease, which is not primarily caused by diabetes or hypertension.
2. Any clinically relevant abnormality in kidney ultrasound, in the urine sediment or urine analysis with dipstick at Visit 1 (decision for exclusion due to clinically relevant abnormalities for protein, glucose and pH measured via dipstick is at discretion of the investigator).
3. Evidence of renal impairment as determined by any one of the following: Serum creatinine clearance < 30 ml/min as determined by Cockroft and Gault and/or serum creatinine > 1.25 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
4. Serum potassium values <3.5 mmol/l or >5.5 mmol/l at Visit 1
5. Any medical condition which might significantly alter the urinary excretion of albumin
6. Fluid depletion; the patient is to be instructed to drink at least 2 l/day, especially during the last day prior Visit 1-4, 9 and 12.
7. Unwillingness or inability to avoid extensive exercise (any sport activity lasting longer than 30 minutes) during the last day prior Visit 1-4, 9 and 12.
8. Active urinary infection
9. Vaginal discharge/fluor and/or vaginal infection
10. Active systemic infection and/or fever
11. Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
12. Severe hypertension defined as grade 3 of WHO classification; mean sitting diastolic blood pressure MSDBP >=110 mm Hg and/or mean sitting systolic blood pressure (MSSBP) >=180 mm Hg
13. Known history of hypotensive symptoms or orthostatic hypotension
14. Type 1 Diabetes mellitus
15. Uncontrolled treated Type 2 Diabetes mellitus with poor glucose control defined as HbA1c > 8.0 % at Visit 1
16. Inability to discontinue all prior anti-hypertensive medications safely for a period of 3 weeks, as required by the protocol
17. Administration of any agent indicated for the treatment of hypertension after the visit 1, permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1
18. Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study
19. Known or suspected contraindications as listed in the basic prescribing information, including history of allergy to ARBs and ACEIs, incl. consideration on contraindications of free add-on medication amlodipine and HCTZ
20. History of hypertensive encephalopathy, coronary artery bypass surgery, percutaneous transluminal angioplasty, transient ischemic cerebral attack, stroke or myocardial infarction during the last 12 months prior to Visit 1
21. Known Keith-Wagener grade III or IV hypertensive retinopathy
22. Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma
23. History of heart failure
24. Second or third degree heart block without a pacemaker
25. Concomitant unstable angina pectoris
26. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
27. Clinically significant valvular heart disease
28. Evidence of hepatic disease or cholestasis as determined by any one of the following: ALT or AST values 2 x ULN at visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt
29. S
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method