MedTrace Logo

BAY94-8862 Dose Finding Trial in Subjects With Chronic Heart Failure and Mild (Part A) or Moderate (Part B) Chronic Kidney Disease

NCT01345656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2022-02-10

No results posted yet for this study

Summary

A placebo (Part A) and placebo and active comparator controlled (Part B), double-blind and randomized study to assess safety and tolerability of a new drug (BAY94-8862) given orally

Conditions

Interventions

DRUG

BAY94-8862

Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks

DRUG

BAY94-8862

Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks

DRUG

BAY94-8862

One 10 mg BAY94-8862 tablet for duration of 4 weeks

DRUG

BAY94-8862

Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks

DRUG

Placebo

Placebo tablets for duration of 4 weeks

DRUG

Spironolactone

Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-09
Primary Completion
2012-05-30
Completion
2012-07-16

Countries

  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Israel
  • Norway
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345656 on ClinicalTrials.gov