HypertensionNCT01118286
Treatment of Hypertension With Adalat® in Combination With Other Drugs
An observational study of Hypertension, run by Bayer at 11 sites in 11 countries.
Trial summary
To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine (Adalat, BAYA1040)
- How many people
- 4,497 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Jan 2010to Sep 2011
- Phase
- Observational
- 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
Study population: Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy
Who may be able to join
- Previously untreated hypertensive patients starting with combination therapy containing nifedipine or
- Insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-CCB (calcium-channel-blocker) containing antihypertensive therapy
Who cannot join
- None. Exclusion criteria are defined by contraindications and precautions as stated in the local product information.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy
To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat, BAYA1040)
- Keywords
- Hypertension, Drug therapy, combination
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Adalat, BAYA1040)Drug
Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy. The decision of including the patient as well as decision on dosage and duration is taken by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Nifedipine (Adalat, BAYA1040) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients
Measured: After three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJan 2010
- Study completionSep 2011
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 BayerThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118286
- Sponsor's protocol ID
- 14296
- Other IDs
- AL0701, AdADOSE
- Status last verified
- Jun 2012
- First submitted
- 5 May 2010
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Motaweih AK, Usova E, Hussain W, Dello Z, Schmidt B, Petri T. Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE). BMC Cardiovasc Disord. 2015 May 9;15:35. doi: 10.1186/s12872-015-0037-x.
PubMed 25956918
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdADOSE - Antihypertensive Treatment With Adalat® in Different Doses and Combination Therapy
- ClinicalTrials.gov ID
- NCT01118286
- Acronym / sponsor ID
- 14296
- Conditions
- Hypertension
- Keywords
- Hypertension, Drug therapy, combination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,497 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Study completion
- Sep 2011 (actual)
- First posted
- 6 May 2010 (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.
To investigate the therapeutic effectiveness of long acting nifedipine containing combination therapy in the treatment of hypertensive patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Nifedipine (Adalat, BAYA1040) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy
Key inclusion criteria (2 listed)
- Previously untreated hypertensive patients starting with combination therapy containing nifedipine or
- Insufficiently controlled hypertensive pts. receiving nifedipine as an add-on to existing non-CCB (calcium-channel-blocker) containing antihypertensive therapy
Key exclusion criteria (1 listed)
- None. Exclusion criteria are defined by contraindications and precautions as stated in the local product information.
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 |
|---|---|---|
| Nifedipine (Adalat, BAYA1040)Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy. The decision of including the patient as well as decision on dosage and duration is taken by the investigator. | Drug | Group 1 |
Primary outcome
Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients
Time frame: After three months
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 27 Jun 2012.
- Derived from this study: PubMed 25956918Motaweih AK, Usova E, Hussain W, Dello Z, Schmidt B, Petri T. Effectiveness of combination therapy with nifedipine GITS: a prospective, 12-week observational study (AdADOSE). BMC Cardiovasc Disord. 2015 May 9;15:35. doi: 10.1186/s12872-015-0037-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.
Bayer Study Director study director
Bayer
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Bayer at 11 sites in 11 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 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 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Bahrain, Egypt, Jordan, Lebanon, Morocco and 6 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?
Evaluation of treatment success (lowering of blood pressure in mmHg) in adult hypertensive patients (time frame: After three months). 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 NCT01118286, 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 27 Jun 2012.