HypertensionPhase 4Sevicontrol-2NCT01611077
Efficacy and Safety of a Therapy Change From Candesartan 32 mg to Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg
A Phase 4 study testing Candesartan cilexetil, Olmesartan medoxomil and Olmesartan/amlodipine in people with Hypertension, run by Institut für Pharmakologie und Präventive Medizin at 11 sites in Germany.
Trial summary
The investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan cilexetil, Olmesartan medoxomil and Olmesartan/amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 11 sitesGermany
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 4
- 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
Who may be able to join
- male or female patients >= 18 years of age
- essential hypertension, i. e. systolic office bp >= 140 mmHg for pre-treated patients or >= 160 mmHg for untreated patients at screening visit and >= 160 mmHg at end of wash-out
- signed IC
Who cannot join
- systolic office bp > 180 mm Hg at screening visit
- known hypertensive retinopathy GIII or IV
- recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
- type I diabetes or poorly controlled (HbA1c >= 8) type II diabetes
- chronic heart failure NYHA III or IV
- prior stroke or TIA
Show all 18Show fewer
- creatinine clearance < 60 ml/min or condition after kidney transplant
- moderately or severely impaired liver function (ALT or AST or bilirubin more than double normal value)
- women of childbearing potential without highly effective contraception, pregnant or breastfeeding women
- concomitant therapy with lithium
- hemodynamically relevant mitral or aortic valve stenosis (>= II°) or hypertrophic obstructive cardiomyopathy
- concomitant therapy with strong CYP3A4 inhibitors or inductors
- african patients
- concomitant severe psychiatric condition that might impair proper intake of study medication
- life expectancy < 6 months
- night shift workers
- known other mandatory indication for treatment with antihypertensive medications
- parallel participation in other clinical trials
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Praxis Dr. Reimer
Anderbeck, 38836
Praxis Dr. Heinz
Bergisch Gladbach, 51429
Praxis Dr. Zemmrich
Berlin, 12043
St.-Josefs-Hospital
Cloppenburg, 49661
Praxis Dr. Pohl
Dresden, 01129
Praxis Dr. Koßler-Wiesweg
Essen, 45138
Praxis Dr. Rövenich
Frankfurt, 65929
Praxis Dr. Strzata
Kapellendorf, 99510
Praxis Dr. Paschmionka
Leipzig, 04316
Praxis Dr. Pitule
Ludwigshafen, 67061
Praxis Dr. Loddo
Rastede, 26180
About this study
Official title: Efficacy and Safety of a Sequential Therapy Change From Candesartan 32 mg to the Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg in Patients With Poorly Controlled Moderate Hypertension - an Open Phase IV Trial
The investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.
Read the detailed description
SEVICONTROL-2:
Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial
- Conditions
- Hypertension
- Being tested
- Candesartan cilexetil, Olmesartan medoxomil, Olmesartan/amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan cilexetilDrug
Also called Atacand
Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days
Olmesartan medoxomilDrug
Also called Olmetec
Switch to olmesartan 40 mg tablets once daily for 42 days,
Olmesartan/amlodipineDrug
Also called Sevikar (r)
then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days Receives: Drug: Candesartan cilexetil; Drug: Olmesartan medoxomil; Drug: Olmesartan/amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values
After six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan.
Measured: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.
Secondary outcomes (1)
Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp)
from candesartan to olmesartan 40 mg and then to a fixed combination of olmesartan 40 mg and amlodipine 10 mg.
Measured: after 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionJan 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Stephan Lüders, Dr.med., Principal investigator, St.-Josefs-Hospital Cloppenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611077
- Sponsor's protocol ID
- Sevicontrol-2
- Acronym
- Sevicontrol-2
- Status last verified
- Feb 2017
- First submitted
- 30 May 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Sequential Therapy Change From Candesartan 32 mg to the Fixed Combination of Olmesartan 40 mg/Amlodipine 10 mg in Patients With Poorly Controlled Moderate Hypertension - an Open Phase IV Trial
- ClinicalTrials.gov ID
- NCT01611077
- Acronym / sponsor ID
- Sevicontrol-2 / Sevicontrol-2
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Jun 2012 (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 investigators want to find out if a treatment with a new combination of two different antihypertensive drugs (olmesartan and amlodipine) in one tablet in patients with moderately elevated blood pressure is more effective than treatment with just one substance (candesartan). All antihypertensive treatment will be ceased for two weeks to achieve comparable baseline conditions. Treatment is then started with the single substance. After six weeks, therapy is changed to another single substance and after a further six weeks, to the fixed combination tablet. Blood pressure is determined by office measurements taken by the doctor and via long-term ambulatory blood pressure monitoring (ABPM). Participants may be male or female and must be over 18 years of age.
Detailed description
SEVICONTROL-2:
Efficacy and Safety of a sequential therapy change from Candesartan 32 mg to the fixed combination of olmesartan 40 mg/amlodipine 10 mg in patients with poorly controlled moderate hypertension - an open phase IV trial
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Drug: Candesartan cilexetil, Drug: Olmesartan medoxomil, Drug: Olmesartan/amlodipineCandesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days, then olmesartan 40 mg tablets once daily for 42 days, then olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female patients >= 18 years of age
- essential hypertension, i. e. systolic office bp >= 140 mmHg for pre-treated patients or >= 160 mmHg for untreated patients at screening visit and >= 160 mmHg at end of wash-out
- signed IC
Key exclusion criteria (18 listed)
- systolic office bp > 180 mm Hg at screening visit
- known hypertensive retinopathy GIII or IV
- recent (< 4 weeks ago) myocardial infarction or indication for coronary or peripheral revascularisation
- type I diabetes or poorly controlled (HbA1c >= 8) type II diabetes
- chronic heart failure NYHA III or 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 |
|---|---|---|
| Candesartan cilexetilAlso: AtacandCandesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days | Drug | Single Arm |
| Olmesartan medoxomilAlso: OlmetecSwitch to olmesartan 40 mg tablets once daily for 42 days, | Drug | Single Arm |
| Olmesartan/amlodipineAlso: Sevikar (r)then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days | Drug | Single Arm |
Primary outcome
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values
Time frame: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.
After six weeks therapy with a monotherapy with olmesartan 40 mg and further six weeks treatment with a fixed combination of olmesartan 40 mg and amlodipine 10 mg compared to previous monotherapy with candesartan.
1 secondary outcome
Change in systolic/diastolic office blood pressure and mean values (night-time and 24 hr for systolic bp and day-time, night-time and 24 hr for diastolic bp)
Time frame: after 6 and 12 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 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Stephan Lüders, Dr.med. principal investigator
St.-Josefs-Hospital Cloppenburg
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan cilexetil, Olmesartan medoxomil and Olmesartan/amlodipine in people with Hypertension, run by Institut für Pharmakologie und Präventive Medizin at 11 sites 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 18 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 23 Feb 2017. 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 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 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?
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?
Change in systolic daytime mean ABPM (long-term ambulatory blood pressure monitoring) values (time frame: ABPM will be performed after 6 weeks treatment with each of the different therapy regimes.). 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 23 Feb 2017.