Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
7 October 2014 |
Main ID: |
EUCTR2011-000301-45-AT |
Date of registration:
|
01/06/2011 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
BAY94-8862 dose finding trial in subjects with chronic heart failure and mild (Part A) or moderate (Part B) chronic kidney disease
|
Scientific title:
|
A randomized, double-blind, multi-center study to assess safety and tolerability of different oral doses of
BAY 94-8862 in subjects with stable chronic heart failure with left ventricular systolic dysfunction and
mild (Part A) or moderate (Part B) chronic kidney disease versus placebo (Part A) or versus placebo and
spironolactone (Part B) - ARTS study |
Date of first enrolment:
|
11/08/2011 |
Target sample size:
|
425 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000301-45 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Other specify the comparator: Spironolactone
Number of treatment arms in the trial: 6
|
Phase:
|
|
|
Countries of recruitment
|
Austria
|
Belgium
|
Czech Republic
|
Denmark
|
Finland
|
Germany
|
Israel
|
Norway
|
Poland
|
Sweden
| | | | | | |
Contacts
|
Name:
|
Bayer Clinical Trials Contact
|
Address:
|
Bayer Pharma AG? – CTP Team / Ref: „EU CTR“, S102 , Level 2, Room 156
13353
Berlin
Germany |
Telephone:
|
|
Email:
|
clinical-trials-contact@bayerhealthcare.com |
Affiliation:
|
Bayer Healthcare AG |
|
Name:
|
Bayer Clinical Trials Contact
|
Address:
|
Bayer Pharma AG? – CTP Team / Ref: „EU CTR“, S102 , Level 2, Room 156
13353
Berlin
Germany |
Telephone:
|
|
Email:
|
clinical-trials-contact@bayerhealthcare.com |
Affiliation:
|
Bayer Healthcare AG |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Men aged 18 years and older or postmenopausal women aged 55 years and older or women aged 18 years and older without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy 2. Clinical diagnosis of CHF (chronic heart failure), either ischemic or non-ischemic, NYHA (New York Heart Association) class II - III, treated with evidenced-based therapy for CHF, e.g. beta-blockers and ACE (angiotensin-converting enzyme) inhibitors or ARB (angiotensin receptor blocker) as well as diuretics, unless contraindicated or not tolerated 3. Known kidney damage for >/= 3 months, as defined by structural or functional abnormalities of the kidney, and -- Part A: 60 mL/min/1.73 m2 = eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m2 (MDRD, Modification of Diet in Renal Disease) at the screening visit -- Part B: 30 mL/min/1.73 m2 = eGFR <= 60 mL/min/1.73 m2 (MDRD) at the screening visit 4. Serum potassium = 4.8 mmol/L at the screening visit 5. Systolic blood pressure >/= 90 mmHg without signs or symptoms of hypotension at the screening visit
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 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria: 1. Known hypersensitivity to the study drug (active substance or excipients) or spironolactone and respective excipients (Part B only) 2. Subjects with anuria, acute renal failure, or Addison’s disease 3. Acute coronary syndrome or unstable coronary artery disease within 30 days prior to randomization 4. Valvular heart disease requiring surgical intervention during the course of the study 5. History of hospitalization for hyperkalemia or acute renal failure induced by previous aldosterone antagonist treatment
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Stable chronic heart failure subjects with left ventricular systolic dysfunction and mild (Part A) or moderate (Part B) chronic kidney disease MedDRA version: 14.1
Level: LLT
Classification code 10008908
Term: Chronic heart failure
System Organ Class: 10007541 - Cardiac disorders
|
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
|
Intervention(s)
|
Product Name: BAY 94-8862 IR tablet 1.25 mg Product Code: BAY 94-8862 coated tablet 1.25 mg Pharmaceutical Form: Film-coated tablet CAS Number: 1050477-31-0 Current Sponsor code: BAY 94-8862 micronized Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Product Name: BAY 94-8862 IR tablet 10 mg Product Code: BAY 94-8862 coated tablet 10 mg Pharmaceutical Form: Film-coated tablet CAS Number: 1050477-31-0 Current Sponsor code: BAY 94-8862 micronized Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Aldactone 25 mg Product Name: Aldactone 25 mg Pharmaceutical Form: Film-coated tablet CAS Number: 52-01-7 Other descriptive name: SPIRONOLACTONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
|
Primary Outcome(s)
|
Main Objective: Part A The safety and tolerability of 3 oral doses of BAY 94 8862 given once daily over 4 weeks in a randomized, placebo-controleld, double-blind study in subjects with chronic heart failure (CHF) with left ventricular systolic dysfunction (LVSD) and mild chronic kidney disease (CKD) (60 mL/min/7.73 m2 => eGFR <90 mL/min/1.73 m2). the effects on serum potassium, the effects of these doses on the change in biomarkers of renal function, eGFR using the Modification of Diet in Renal Disease Study Group (MDRD) formula, albuminuria, and pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses. Part B To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks in a randomized, placebo-controlled, double-blind study design versus placebo in subjects with CHF with LVSD adn moderate CKD (30 mL/min/1.73 m2=
|
Secondary Objective: Secondary objectives of Part B of the study are: To investigate the change of serum potassium after treatment with 4 oral dosages of BAY 94 8862 given once or twice daily over 4 weeks versus the active comparator spironolactone in subjects with CHF with LVSD and moderate CKD (30 mL/min/1.73 m2 =< eGFR =<60 mL/min/1.73 m2). To assess safety and tolerability of these doses, the effect on cardiac function by changes in concentrations of various biomarkers, and the change in biomarkers of renal function, eGFR (MDRD), and albuminuria. In addition, pharmacokinetics of BAY 94 8862 and its metabolites in plasma after multiple oral doses will be assessed.
|
Primary end point(s): Change in serum potassium
|
Timepoint(s) of evaluation of this end point: 4 weeks
|
Secondary Outcome(s)
|
Secondary end point(s): Change in serum magnesium , change in blood pressure, change in heart rate
|
Timepoint(s) of evaluation of this end point: Day 8, Day 15, Day 22, Day 29
|
Secondary ID(s)
|
BAY94-8862/14563
|
2011-000301-45-SE
|
Source(s) of Monetary Support
|
Bayer HealthCare AG
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|