Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 133 for:    PAP children

Losartan Therapy in Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00519870
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 23, 2007
Sponsor:
Information provided by:
Baskent University

Tracking Information
First Submitted Date  ICMJE August 22, 2007
First Posted Date  ICMJE August 23, 2007
Last Update Posted Date August 23, 2007
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Losartan Therapy in Pulmonary Hypertension
Official Title  ICMJE Losartan Decreases Pulmonary Artery Pressure and Improves Exercise Capacity in Patients With Pulmonary Hypertension
Brief Summary In addition to being effective vasodilators, angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) exert neurohumoral inhibitory actions, such as the inhibition of vascular remodeling and smooth muscle cell proliferation and the amelioration of endothelial dysfunction. These beneficial effects, render those agents appropriate for use in the treatment of pulmonary hypertension. However, data regarding the use of ACEIs or ARBs in the treatment of PHT are limited. In this study, efficacy of an ARB, losartan was compared with those of the calcium channel blocker, nifedipine in the treatment of pulmonary hypertension using echocardiographic, 6-minute walk test (6MWT), cardiopulmonary exercise test, and endothelin-1 levels.Losartan is as effective as nifedipine for reducing Doppler echocardiographically measured PAP and improving exercise capacity on 6MWT and CPET. However the short-term use of losartan or nifedipine had no statistically significant effect on endothelin-1 levels in patients with PHT.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE
  • Drug: nifedipine, losartan
    I: nifedipine 30 mg/d II: losartan 50 mg/d
    Other Names:
    • nifedipine (Adalat Crono, Bayer AG, Leverkusen, Germany)
    • losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA)
  • Drug: losartan
    II: losartan
    Other Name: losartan (Cozaar, Merck Sharp & Dohme, Wilmington, DE, USA) 50 mg/d
  • Drug: Nifedipine, losartan
    I: nifedipine II: losartan
Study Arms Active Comparator: I, II
I: nifedipine II: losartan
Interventions:
  • Drug: nifedipine, losartan
  • Drug: losartan
  • Drug: Nifedipine, losartan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date July 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pulmonary hypertension diagnosed by Doppler echocardiographic examination (a mean pulmonary artery pressure of > 26mmHg)

Exclusion Criteria:

  • acute infectious or inflammatory disease,
  • exacerbation of chronic obstructive pulmonary disease,
  • malignancy,
  • acute coronary syndrome in the last 4 weeks,
  • uncontrolled arrhythmia and hypertension,
  • decompensated heart failure,
  • acute pulmonary emboli,
  • thrombus in a lower extremity,
  • oxygen saturation below 85% at rest,
  • failure to cooperate with CPET
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00519870
Other Study ID Numbers  ICMJE KA04/127
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Baskent University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Serife Savas Bozbas, MD Baskent University Faculty of Medicine, Department of Pulmonary Disease
Study Chair: Fusun Oner Eyuboglu, MD Baskent University Faculty of Medicine, Department of Pulmonary Disease
PRS Account Baskent University
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP