HypertensionNCT00160160
Comparison of Eprosartan/HCT Versus Enalapril/HCT in Hypertensives With Type II Diabetes
A study testing eprosartan/HCTZ in people with Hypertension and Type 2 Diabetes, run by Solvay Pharmaceuticals at 63 sites in 9 countries.
Trial summary
This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension, Type 2 Diabetes
- What is being tested?
- eprosartan/HCTZ
- How many people
- 440 participants
- Where
- 63 sitesin 9 countries
- Study dates
- Oct 2004to not given
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- essential hypertension,
- diabetes type 2
Who cannot join
- severe cardiovascular disease,
- grade 3 hypertension,
- secondary hypertension,
- abnormal liver enzymes
Trial locations and contacts
63 sites in 9 countries.
63 sites in 9 countries
France15 sites
Site 4
Anzin
Site 3
Blois
Site 10
Chemellier
Site 11
Cholet
Site 15
Cholet
Site 16
Cholet
Site 14
La Jubaudière
Site 13
Le Mesnil-en-Vallée
Site 7
Mûrs-Erigné
Site 12
Saint Pierre Montlim
Site 9
Saumur
Site 8
Segré
Site 6
Thouars
Site 2
Tours
Site 5
Vieux-Condé
Germany9 sites
Site 20
Bad Muenster
Site 22
Flörsheim
Site 19
Kirweiler
Site 21
Lambrecht
Site 25
Lindau
Site 18
Lüneburg
Site 24
Lutherstadt
Site 17
Riesa
Site 23
Waldbrunn
Italy7 sites
Site 62
Bologna
Site 60
Naples
Site 58
Padova
Site 59
Palermo
Site 63
Pavia
Site 61
Pisa
Site 64
Torino
Spain7 sites
Site 55
Badajoz
Site 51
Badalona
Site 56
Barcelona
Site 57
Barcelona
Site 54
Ciudad Real
Site 53
Granada
Site 52
Madrid
Canada6 sites
Site 26
Calgary
Site 27
Montreal
Site 30
Québec
Site 31
Thornhill
Site 28
Vancouver
Site 29
Winnipeg
Sweden6 sites
Site 48
Ängelholm
Site 47
Gothenburg
Site 46
Helsingborg
Site 45
Kristianstat
Site 50
Malmö
Site 49
Stockholm
United Kingdom6 sites
Site 33
Aberdeen
Site 36
Bath
Site 37
Liverpool
Site 34
Manchester
Site 32
Oldham
Site 35
Rugby
About this study
Official title: A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2
This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.
- Conditions
- Hypertension, Type 2 Diabetes
- Being tested
- eprosartan/HCTZ
- Keywords
- comparator trial, hypertension, diabetes, blood pressure
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eprosartan/HCTZDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
Secondary outcomes (1)
Comparison of responder rates
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 startOct 2004
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 440 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
- NCT00160160
- Sponsor's protocol ID
- S171.3.012
- Other IDs
- 2004-00703-18, 2004
- Status last verified
- Jan 2009
- First submitted
- 8 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
- A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2
- ClinicalTrials.gov ID
- NCT00160160
- Acronym / sponsor ID
- S171.3.012
- Conditions
- Hypertension, Type 2 Diabetes
- Keywords
- comparator trial, hypertension, diabetes, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- 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.
This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- essential hypertension,
- diabetes type 2
Key exclusion criteria (4 listed)
- severe cardiovascular disease,
- grade 3 hypertension,
- secondary hypertension,
- abnormal liver enzymes
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 |
|---|---|---|
| eprosartan/HCTZ | Drug | – |
Primary outcome
Blood pressure reduction
1 secondary outcome
Comparison of responder rates
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
63 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eprosartan/HCTZ in people with Hypertension and Type 2 Diabetes, run by Solvay Pharmaceuticals at 63 sites in 9 countries.
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 2 inclusion and 4 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 63 sites in France, Germany, Italy, Spain, Canada and 4 more countries. 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.
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?
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.