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A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction

NCT ID: NCT01172756

Last Updated: 2014-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-10-31

Brief Summary

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The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction

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Detailed Description

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Conditions

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Hypertension, Pulmonary Ventricular Dysfunction, Left

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

0.5 mg single oral dose

Arm 2

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

1 mg single oral dose

Arm 3

Group Type EXPERIMENTAL

Riociguat (BAY63-2521)

Intervention Type DRUG

2 mg single oral dose

Arm 4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single oral dose

Interventions

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Riociguat (BAY63-2521)

0.5 mg single oral dose

Intervention Type DRUG

Riociguat (BAY63-2521)

1 mg single oral dose

Intervention Type DRUG

Riociguat (BAY63-2521)

2 mg single oral dose

Intervention Type DRUG

Placebo

single oral dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients with symptomatic pulmonary hypertension due to left ventricular diastolic dysfunction

Exclusion Criteria

* Types of pulmonary hypertension other than group 2.2 of Dana Point Classification
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Graz, Styria, Austria

Site Status

Graz, Styria, Austria

Site Status

Linz, Upper Austria, Austria

Site Status

Vienna, Vienna, Austria

Site Status

Salzburg, , Austria

Site Status

Prague, , Czechia

Site Status

Cologne, North Rhine-Westphalia, Germany

Site Status

Countries

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Austria Czechia Germany

References

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Bonderman D, Pretsch I, Steringer-Mascherbauer R, Jansa P, Rosenkranz S, Tufaro C, Bojic A, Lam CSP, Frey R, Ochan Kilama M, Unger S, Roessig L, Lang IM. Acute hemodynamic effects of riociguat in patients with pulmonary hypertension associated with diastolic heart failure (DILATE-1): a randomized, double-blind, placebo-controlled, single-dose study. Chest. 2014 Nov;146(5):1274-1285. doi: 10.1378/chest.14-0106.

Reference Type DERIVED
PMID: 24991733 (View on PubMed)

Related Links

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http://www.clinicaltrialsregister.eu

Click here and search for information of Bayer products for Europe

Other Identifiers

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2010-018436-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14554

Identifier Type: -

Identifier Source: org_study_id

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