Blood PressurePhase 4NOAAHNCT01030458
Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial
A Phase 4 study testing amlodipine 5/10 mg per day plus valsartan 160 mg/day and hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day in people with Blood Pressure, run by KU Leuven at 7 sites in 5 countries.
Trial summary
The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- amlodipine 5/10 mg per day plus valsartan 160 mg/day and hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
- Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
- Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
- Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
- The patient must provide informed written consent.
Who cannot join
- Premenopausal women not applying anticonception.
- A history of cardiovascular disease.
- Secondary hypertension.
- Electrocardiographic left ventricular hypertrophy.
- More than two cardiovascular risk factors in addition to hypertension.
- Diabetes mellitus.
Show all 10Show fewer
- Renal dysfunction.
- Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.
- Severe non-cardiovascular disease.
- Known contra indications for the first-line study medications.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Cameroon2 sites
Ecole de Médecine de Douala
Douala
Hôpital Général de Yaoundé
Yaoundé, BP 5408
About this study
Official title: Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial
The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.
Read the detailed description
Primary objective:
Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.
Secondary
- To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic;
- To compare the duration of follow-up, during which a steady blood pressure control will be achieved;
- To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;
- To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.
- Conditions
- Blood Pressure
- Being tested
- amlodipine 5/10 mg per day plus valsartan 160 mg/day, hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day
- Keywords
- Blood pressure, Hypertension, Blacks, Africa, Blood pressure control, Side-effects
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine 5/10 mg per day plus valsartan 160 mg/dayDrug
Also called ExForge®
Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/dayDrug
Also called Lodoz®
hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning
| Study group | Role | What they receive |
|---|---|---|
| amlodipine plus valsartan | Experimental | In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. Receives: Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/day |
| hydrochlorothiazide plus bisoprolol | Active comparator | In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol Receives: Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting Systolic Blood Pressure on Automated Measurement
Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.
Measured: 6 months follow-up after randomization
Secondary outcomes (3)
Time to Blood Pressure Control
The time (in weeks) after randomisation that will be required to reach and maintain the target, defined as a blood pressure below 140 mmHg systolic and 90 mmHg diastolic.
Measured: 6 months follow-up after randomization
Side-effects to Study Medications
Measured: 6 months follow-up after randomization
Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
This variable gives the proportion of patients reaching blood pressure control over time (< 140 mmHg systolic and < 90 mmHg diastolic)
Measured: 6 months follow-up after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startSep 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kinshasa, Yaounde Central Hospital, University of Yaounde, University of Libreville, Institute of Cardiology Abidjan, University of Ilorin Teaching Hospital, University of Nigeria, Enugu Campus, Hospital Aristide Le Dantec, Dakar, Senegal
- Responsible party
- Principal investigator, Jan A. Staessen, KU Leuven
- Investigators
- Samuel Kingue, MD, Principal investigator, Hôpital Général de Yaoundé, BP 5408, Yaoundé, CamerounDaniel Lemogoum, MD, PhD, Principal investigator, Université de Douala, Douala, CameroonBruno Mipinda, MD, Principal investigator, Hôpital Central Universitaire de Libreville, Libreville, GabonOmotoso Babatunde, MD, Principal investigator, University of Ilorin, Ilorin, NigeriaIfeoma E Ulasi, MD, Principal investigator, University of Enugu, Enugu, NigeriaSerigne Abdou Ba, MD, Principal investigator, Hôpital Aristide Le Dantec, Dakar, SénégalJean-René M'Buyamba-Kabangu, MD, PhD, Study chair, University of Kinshasa, Kinshasa, Democratic Republic of CongoJan A Staessen, MD, PhD, Study director, University of Leuven, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030458
- Sponsor's protocol ID
- NOAAH version 5.0.2
- Acronym
- NOAAH
- Status last verified
- Nov 2013
- First submitted
- 9 Dec 2009
- Last updated
- 9 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Odili AN, Richart T, Thijs L, Kingue S, Boombhi HJ, Lemogoum D, Kaptue J, Kamdem MK, Mipinda JB, Omotoso BA, Kolo PM, Aderibigbe A, Ulasi II, Anisiuba BC, Ijoma CK, Ba SA, Ndiaye MB, Staessen JA, M'buyamba-Kabangu JR; NOAAH Investigators. Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial. Blood Press. 2011 Oct;20(5):256-66. doi: 10.3109/08037051.2011.572614. Epub 2011 Apr 15.
PubMed 21495829M'Buyamba-Kabangu JR, Anisiuba BC, Ndiaye MB, Lemogoum D, Jacobs L, Ijoma CK, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Osakwe CE, Odili A, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, Staessen JA; Newer versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Efficacy of newer versus older antihypertensive drugs in black patients living in sub-Saharan Africa. J Hum Hypertens. 2013 Dec;27(12):729-35. doi: 10.1038/jhh.2013.56. Epub 2013 Jun 27.
PubMed 23803591Osakwe CE, Jacobs L, Anisiuba BC, Ndiaye MB, Lemogoum D, Ijoma CK, Kamdem MM, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Odili AN, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, M'buyamba-Kabangu JR, Staessen JA; Newer Versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Heart rate variability on antihypertensive drugs in black patients living in sub-Saharan Africa. Blood Press. 2014 Jun;23(3):174-80. doi: 10.3109/08037051.2013.836810. Epub 2013 Sep 25.
PubMed 24066715Odili AN, Ezeala-Adikaibe B, Ndiaye MB, Anisiuba BC, Kamdem MM, Ijoma CK, Kaptue J, Boombhi HJ, Kolo PM, Shu EN, Thijs L, Staessen JA, Omotoso BA, Kingue S, Ba SA, Lemogoum D, M'Buyamba-Kabangu JR, Ulasi II. Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients. Trials. 2012 May 17;13:59. doi: 10.1186/1745-6215-13-59.
PubMed 22594907
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newer vs Older Antihypertensive Agents in African Hypertensive Patients Trial
- ClinicalTrials.gov ID
- NCT01030458
- Acronym / sponsor ID
- NOAAH / NOAAH version 5.0.2
- Conditions
- Blood Pressure
- Keywords
- Blood pressure, Hypertension, Blacks, Africa, Blood pressure control, Side-effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- University of Kinshasa, Yaounde Central Hospital, University of Yaounde, University of Libreville, Institute of Cardiology Abidjan, University of Ilorin Teaching Hospital, University of Nigeria, Enugu Campus, Hospital Aristide Le Dantec, Dakar, Senegal
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 15 Nov 2013
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 compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.
Detailed description
Primary objective:
Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.
Secondary
- To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic;
- To compare the duration of follow-up, during which a steady blood pressure control will be achieved;
- To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;
- To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amlodipine plus valsartan | Experimental | Drug: amlodipine 5/10 mg per day plus valsartan 160 mg/dayIn the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan. |
| hydrochlorothiazide plus bisoprolol | Active comparator | Drug: hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/dayIn the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
- Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
- Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
- Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
- The patient must provide informed written consent.
Key exclusion criteria (10 listed)
- Premenopausal women not applying anticonception.
- A history of cardiovascular disease.
- Secondary hypertension.
- Electrocardiographic left ventricular hypertrophy.
- More than two cardiovascular risk factors in addition to hypertension.
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 5/10 mg per day plus valsartan 160 mg/dayAlso: ExForge®Amlodipine 5/10 mg/day plus valsartan 160 mg/day, once daily, in the morning | Drug | amlodipine plus valsartan |
| hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/dayAlso: Lodoz®hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day, once daily, in the morning | Drug | hydrochlorothiazide plus bisoprolol |
Primary outcome
Sitting Systolic Blood Pressure on Automated Measurement
Time frame: 6 months follow-up after randomization
Blood pressure is measured by means of validated oscillometric OMRON 705IT recorders (OMRON Healthcare Europe BV, Nieuwegein, Netherlands), after the patient has been seated for 5 minutes in a quiet room, according to the ESC/ESH guidelines. Three consecutive blood pressure readings are obtained and the average of these 3 measurements is used as the primary outcome.
3 secondary outcomes
Time to Blood Pressure Control
Time frame: 6 months follow-up after randomization
Side-effects to Study Medications
Time frame: 6 months follow-up after randomization
Proportion of Patients Reaching Blood Pressure Control at the End of Follow-up
Time frame: 6 months follow-up after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21495829Odili AN, Richart T, Thijs L, Kingue S, Boombhi HJ, Lemogoum D, Kaptue J, Kamdem MK, Mipinda JB, Omotoso BA, Kolo PM, Aderibigbe A, Ulasi II, Anisiuba BC, Ijoma CK, Ba SA, Ndiaye MB, Staessen JA, M'buyamba-Kabangu JR; NOAAH Investigators. Rationale and design of the Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) trial. Blood Press. 2011 Oct;20(5):256-66. doi: 10.3109/08037051.2011.572614. Epub 2011 Apr 15.
- Results publication: PubMed 23803591M'Buyamba-Kabangu JR, Anisiuba BC, Ndiaye MB, Lemogoum D, Jacobs L, Ijoma CK, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Osakwe CE, Odili A, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, Staessen JA; Newer versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Efficacy of newer versus older antihypertensive drugs in black patients living in sub-Saharan Africa. J Hum Hypertens. 2013 Dec;27(12):729-35. doi: 10.1038/jhh.2013.56. Epub 2013 Jun 27.
- Derived from this study: PubMed 24066715Osakwe CE, Jacobs L, Anisiuba BC, Ndiaye MB, Lemogoum D, Ijoma CK, Kamdem MM, Thijs L, Boombhi HJ, Kaptue J, Kolo PM, Mipinda JB, Odili AN, Ezeala-Adikaibe B, Kingue S, Omotoso BA, Ba SA, Ulasi II, M'buyamba-Kabangu JR, Staessen JA; Newer Versus Older Antihypertensive Agents in African Hypertensive Patients Trial (NOAAH) Investigators. Heart rate variability on antihypertensive drugs in black patients living in sub-Saharan Africa. Blood Press. 2014 Jun;23(3):174-80. doi: 10.3109/08037051.2013.836810. Epub 2013 Sep 25.
- Derived from this study: PubMed 22594907Odili AN, Ezeala-Adikaibe B, Ndiaye MB, Anisiuba BC, Kamdem MM, Ijoma CK, Kaptue J, Boombhi HJ, Kolo PM, Shu EN, Thijs L, Staessen JA, Omotoso BA, Kingue S, Ba SA, Lemogoum D, M'Buyamba-Kabangu JR, Ulasi II. Progress report on the first sub-Saharan Africa trial of newer versus older antihypertensive drugs in native black patients. Trials. 2012 May 17;13:59. doi: 10.1186/1745-6215-13-59.
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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.
Samuel Kingue, MD principal investigator
Hôpital Général de Yaoundé, BP 5408, Yaoundé, Cameroun
Daniel Lemogoum, MD, PhD principal investigator
Université de Douala, Douala, Cameroon
Bruno Mipinda, MD principal investigator
Hôpital Central Universitaire de Libreville, Libreville, Gabon
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing amlodipine 5/10 mg per day plus valsartan 160 mg/day and hydrochlorothiazide 6.25 mg/day plus bisoprolol 5/10 mg/day in people with Blood Pressure, run by KU Leuven at 7 sites in 5 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 5 inclusion and 10 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 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Cameroon, Nigeria, Côte d’Ivoire, Gabon, Senegal. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sitting Systolic Blood Pressure on Automated Measurement (time frame: 6 months follow-up after randomization). 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 NCT01030458, which also lists 4 linked publications.
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 9 Dec 2013.