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Efficacy and Safety of Moxonidine in Indian Patients

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00160277
First received: September 9, 2005
Last updated: January 29, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.


Condition Intervention Phase
Hypertension
 Drug: Moxonidine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Multi-Center, Force-Titration Study to Evaluate the Efficacy and Safety of Moxonidine in Ambulatory Subjects With Essential Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Systolic blood pressure reduction

Secondary Outcome Measures:
  • Piggy-back pharmacoeconomic evaluation; Safety and tolerability

Estimated Enrollment: 100
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Hypertension

Exclusion Criteria:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160277

Locations
India
Site 1
Jubillee Hills Hyderabad, India
Site 2
Mangalore, India
Site 3
New Delhi, India
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00160277     History of Changes
Other Study ID Numbers: S220.3.124
Study First Received: September 9, 2005
Last Updated: January 29, 2009
Health Authority: India: Indian Council of Medical Research

Keywords provided by Solvay Pharmaceuticals:
Efficacy and safety of moxonidine in Indian hypertensives

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Moxonidine
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013