HypertensionPhase 3NCT00627952
A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients
A Phase 3 study testing amlodipine 10 mg, manidipine 20 mg and amlodipine 5 mg + delapril 30 mg in people with Hypertension, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- amlodipine 10 mg, manidipine 20 mg and amlodipine 5 mg + delapril 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Dec 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients aged 18 years or older
- mild to moderate hypertension (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg)
Who cannot join
- secondary form of arterial hypertension
- severe hypertension (systolic blood pressure > 179 mmHg or diastolic blood pressure > 109 mmHg)
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg
Erlangen, Bavaria, 91054
About this study
Official title: Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients
Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.
Read the detailed description
The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.
- Conditions
- Hypertension
- Being tested
- amlodipine 10 mg, manidipine 20 mg, amlodipine 5 mg + delapril 30 mg, manidipine 10 mg + delapril 30 mg
- Keywords
- hypertension, intraglomerular pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine 10 mgDrug
amlodipine 10 mg once daily
manidipine 20 mgDrug
manidipine 20 mg once daily
amlodipine 5 mg + delapril 30 mgDrug
amlodipine 5 mg + delapril 30 mg once daily
manidipine 10 mg + delapril 30 mgDrug
manidipine 10 mg + delapril 30 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| amlodipine 10 mg | Active comparator | Not described Receives: Drug: amlodipine 10 mg; Drug: amlodipine 5 mg + delapril 30 mg |
| manidipine 20 mg | Active comparator | Not described Receives: Drug: manidipine 20 mg; Drug: manidipine 10 mg + delapril 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
Measured: 4 weeks
Secondary outcomes (1)
effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Principal investigator, Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
- Investigators
- Roland E Schmieder, Professor, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627952
- Sponsor's protocol ID
- 2006-006350-10
- Other IDs
- MANTRA
- Status last verified
- Jan 2013
- First submitted
- 24 Feb 2008
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.
PubMed 29268712
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00627952
- Acronym / sponsor ID
- 2006-006350-10
- Conditions
- Hypertension
- Keywords
- hypertension, intraglomerular pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Mar 2008 (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.
Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.
Detailed description
The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amlodipine 10 mg | Active comparator | Drug: amlodipine 10 mg, Drug: amlodipine 5 mg + delapril 30 mg |
| manidipine 20 mg | Active comparator | Drug: manidipine 20 mg, Drug: manidipine 10 mg + delapril 30 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female patients aged 18 years or older
- mild to moderate hypertension (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg)
Key exclusion criteria (3 listed)
- secondary form of arterial hypertension
- severe hypertension (systolic blood pressure > 179 mmHg or diastolic blood pressure > 109 mmHg)
- pregnant or lactating women
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 |
|---|---|---|
| amlodipine 10 mgamlodipine 10 mg once daily | Drug | amlodipine 10 mg |
| manidipine 20 mgmanidipine 20 mg once daily | Drug | manidipine 20 mg |
| amlodipine 5 mg + delapril 30 mgamlodipine 5 mg + delapril 30 mg once daily | Drug | amlodipine 10 mg |
| manidipine 10 mg + delapril 30 mgmanidipine 10 mg + delapril 30 mg once daily | Drug | manidipine 20 mg |
Primary outcome
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
Time frame: 4 weeks
1 secondary outcome
effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure
Time frame: 4 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 21 Jan 2013.
- Derived from this study: PubMed 29268712Bosch AJ, Harazny JM, Kistner I, Friedrich S, Wojtkiewicz J, Schmieder RE. Retinal capillary rarefaction in patients with untreated mild-moderate hypertension. BMC Cardiovasc Disord. 2017 Dec 21;17(1):300. doi: 10.1186/s12872-017-0732-x.
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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, Professor principal investigator
University of Erlangen-Nürnberg
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 amlodipine 10 mg, manidipine 20 mg and amlodipine 5 mg + delapril 30 mg in people with Hypertension, 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 2 inclusion and 3 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 21 Jan 2013. 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. 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?
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627952, which also lists 1 linked publication.
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 21 Jan 2013.