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Efficacy and Safety of Moxonidine in Indian Patients

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: NCT00160277
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 30, 2009
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date January 30, 2009
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2006)
Systolic blood pressure reduction
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2006)
Piggy-back pharmacoeconomic evaluation; Safety and tolerability
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Moxonidine in Indian Patients
Official Title  ICMJE Open Label, Multi-Center, Force-Titration Study to Evaluate the Efficacy and Safety of Moxonidine in Ambulatory Subjects With Essential Hypertension
Brief Summary The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: Moxonidine
Study Arms  ICMJE Not Provided
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
 (submitted: May 11, 2006)
100
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Hypertension

Exclusion Criteria:

Severe concomitant diseases, CHF, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00160277
Other Study ID Numbers  ICMJE S220.3.124
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Solvay Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
PRS Account Solvay Pharmaceuticals
Verification Date January 2009

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