HypertensionPhase 3NCT00328393
Effect of Pioglitazone on Ambulatory Blood Pressure
A Phase 3 study testing Pioglitazone in people with Hypertension and Diabetes Mellitus Type 2, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Hypertension, Diabetes Mellitus Type 2
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Jan 2011
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-75 years
- Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
- Casual blood pressure > = 130/80 mmHg, < 160/100 mmHg
Who cannot join
- Therapy with insulin
- Combination therapy of sulfonyl-urea und metformin
- Therapy with nateglinid, repaglinid or an other substance of this drug family
- Allergy against pioglitazone or other composites of the tablet
- History of heart failure (NYHA I bis IV)
- Hepatic insufficiency
Show all 11Show fewer
- Transaminases > 2.5-fold of the upper normal limit
- End-stage renal failure
- Syndrome of polycystic ovaries
- Absence of effective contraception in women of childbearing potential
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
The anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.
- Conditions
- Hypertension, Diabetes Mellitus Type 2
- Being tested
- Pioglitazone, Placebo
- Keywords
- Hypertension
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
45 mg 8 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Active comparator | Pioglitazone 45 mg, 8 weeks Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median of systolic 24-hour ambulatory blood pressure
Change of 24-hour blood pressure after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (1)
Median of 24-hour diastolic ambulatory blood pressure
Change of 24-hour diastolic blood pressure after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMar 2007
- Primary completionMar 2007
- Study completionJan 2011
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.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E Schmieder, Prof., Principal investigator, University of Erlangen-Nürnberg, Medical Department 4
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328393
- Sponsor's protocol ID
- 2005-000570-52
- Other IDs
- 2005
- Status last verified
- Jul 2012
- First submitted
- 17 May 2006
- Last updated
- 10 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on Ambulatory Blood Pressure
- ClinicalTrials.gov ID
- NCT00328393
- Acronym / sponsor ID
- 2005-000570-52
- Conditions
- Hypertension, Diabetes Mellitus Type 2
- Keywords
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2007 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 19 May 2006 (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 anti-diabetic pioglitazone has been found to reduce casual blood pressure. To date, no data are available looking at this effect in detail. Especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: PioglitazonePioglitazone 45 mg, 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 45-75 years
- Diabetes mellitus Type 2 (HbA1c 7 - 8.5%)
- Casual blood pressure > = 130/80 mmHg, < 160/100 mmHg
Key exclusion criteria (11 listed)
- Therapy with insulin
- Combination therapy of sulfonyl-urea und metformin
- Therapy with nateglinid, repaglinid or an other substance of this drug family
- Allergy against pioglitazone or other composites of the tablet
- History of heart failure (NYHA I bis IV)
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 |
|---|---|---|
| Pioglitazone45 mg 8 weeks | Drug | Pioglitazone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Median of systolic 24-hour ambulatory blood pressure
Time frame: 8 weeks
Change of 24-hour blood pressure after 8 weeks of treatment
1 secondary outcome
Median of 24-hour diastolic ambulatory blood pressure
Time frame: 8 weeks
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 10 Jul 2012.
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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.
Roland E Schmieder, Prof. principal investigator
University of Erlangen-Nürnberg, Medical Department 4
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone in people with Hypertension and Diabetes Mellitus Type 2, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 3 inclusion and 11 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Median of systolic 24-hour ambulatory blood pressure (time frame: 8 weeks). 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 10 Jul 2012.