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Clinical Trials/CTRI/2010/091/001390
CTRI/2010/091/001390
Recruiting
Phase 2

Phase-2 comparative clinical trial to assess the efficacy and safety of sodium nitroprusside inhalation in treatment of secondary pulmonary hypertension & hypoxemic conditions (as a life saving/supporting procedure)

Defence R&D Organisation0 sites135 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Defence R&D Organisation
Enrollment
135
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Defence R&D Organisation

Eligibility Criteria

Inclusion Criteria

  • •a) Healthy volunteers
  • •1\. Healthy Males/females, between 18\-45 years ages group
  • •2\. On no permanent treatment
  • •3\. Suffering from no permanent / recurrent / chronic disease or disability
  • •b) Diseased subjects
  • •1\. Worked up adult patients with pulmonary hypertension with associated mild or moderate asthma or COPD or ILD with hypoxemia. Wherever facilities are not available, for example at high altitude, clinical diagnosis shall be deemed sufficient as per accepted norms.
  • •2\. Age group: 18\-65 years
  • •3\. Ambulatory, preferably admitted patients for better follow up
  • •4\. Non\-critically ill patients.

Exclusion Criteria

  • •a) Healthy volunteers
  • •1\. Those who do not sign the ICF
  • •2\. Those who refuse to abide by the rules/briefing and are not able to inhale aerosols as per instructions.
  • •3\. Those who have had any medical condition which in the judgement of the investigator may render them inappropriate for participation in the trial.
  • •4\. Patients who have received any other investigational drug for the last 1 month.
  • •5\. Too low or too high body weight (\< 40 kg, \> 100 kg)
  • •6\. Pregnant \& lactating women
  • •b) Diseased subjects
  • •1\. Patients with prior hypersensitivity to nitrates
  • •2\. Patients who are unwilling to give informed consent.

Outcomes

Primary Outcomes

Not specified

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