HypertensionPhase 3NCT00160277
Efficacy and Safety of Moxonidine in Indian Patients
A Phase 3 study testing Moxonidine in people with Hypertension, run by Solvay Pharmaceuticals at 3 sites in India.
Trial summary
The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Moxonidine
- How many people
- 100 participants
- Where
- 3 sitesIndia
- Study dates
- Jul 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension
Who cannot join
- Severe concomitant diseases, CHF, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Open Label, Multi-Center, Force-Titration Study to Evaluate the Efficacy and Safety of Moxonidine in Ambulatory Subjects With Essential Hypertension
The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.
- Conditions
- Hypertension
- Being tested
- Moxonidine
- Keywords
- Efficacy and safety of moxonidine in Indian hypertensives
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxonidineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure reduction
Secondary outcomes (1)
Piggy-back pharmacoeconomic evaluation; Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160277
- Sponsor's protocol ID
- S220.3.124
- Status last verified
- Jan 2009
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Multi-Center, Force-Titration Study to Evaluate the Efficacy and Safety of Moxonidine in Ambulatory Subjects With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00160277
- Acronym / sponsor ID
- S220.3.124
- Conditions
- Hypertension
- Keywords
- Efficacy and safety of moxonidine in Indian hypertensives
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate efficacy and safety of Moxonidine in Indian subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertension
Key exclusion criteria (1 listed)
- Severe concomitant diseases, CHF, secondary hypertension, severe hypertension, significant hepatic disease, unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxonidine | Drug | – |
Primary outcome
Systolic blood pressure reduction
1 secondary outcome
Piggy-back pharmacoeconomic evaluation; Safety and tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxonidine in people with Hypertension, run by Solvay Pharmaceuticals at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure reduction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.