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HypertensionPhase 3Sevicontrol1NCT01613209

Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine

A Phase 3 study testing Candesartan cilexetil and Olmesartan/Amlodipin in people with Hypertension, run by Institut für Pharmakologie und Präventive Medizin at 12 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. 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 and Olmesartan/Amlodipin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
12 sitesGermany
Study dates
Dec 2011to Oct 2012
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • essential hypertension, i. e. systolic OPM >=140 mmHg at screening and >=160 mmHg after two weeks wash-out

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 17Show 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Germany12 sites

  • Praxis Dr. Reimer

    Anderbeck, 38836

  • Praxis Dr. Heinz

    Bergisch Gladbach, 51429

  • Praxis Dr. Zemmrich

    Berlin, 12043

  • Praxis Dr. Biedermann

    Blankenhain, 99444

  • St.-Josefs-Hospital

    Cloppenburg, 49661

  • Praxis Dr. Pohl

    Dresden, 01129

  • Praxis Koßler-Wiesweg

    Essen, 45138

  • Praxis Dr. Rövenich

    Frankfurt, 65929

  • Praxis Dr. Strzata

    Kapellendorf, 99510

  • Praxis Dr. Paschmionka

    Leipzig, Saxony, 04316

  • Praxis Dr. Pitule

    Ludwigshafen, 67061

  • Praxis Dr. Loddo

    Rastede, Lower Saxony, 26180

Other trials in Germany

About this study

Official title: Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan 40 mg / Amlodipine 10 mg in Patients With Insufficiently Controlled Hypertension Under Monotherapy With Candesartan 32 mg - an Open Phase IIIb Trial

The investigators want to find out whether a recently introduced combination of two blood pressure lowering agents (olmesartan and amlodipine) has a different blood pressure lowering effect than a single active substance. In addition the investigators want to find out whether there is a difference in the changes in blood pressure over the course of a day depending on the time when the medications are taken (in the morning or at night). Male and female patients over 18 years of age may participate.

Read the detailed description

Investigation of changes in blood pressure after six weeks therapy with a fixed combination of 40 mg olmesartan and 10 mg amlodipine compared to a monotherapy with 32 mg candesartan. Investigation of changes in dipping-profile after a further six weeks of therapy with the fixed combination when time of intake is switched from morning to evening.

Conditions
Hypertension
Being tested
Candesartan cilexetil, Olmesartan/Amlodipin
Keywords
Hypertension, ABPM, office blood pressure, olmesartan, amlodipine, fixed combination, time of intake
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

    candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,

  • Olmesartan/AmlodipinDrug

    Also called Sevikar(r)

    olmesartan/amlodipine 40/5 mg tablets for 14 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 28 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 42 days (evening)

Study groups in NCT01613209
Study groupRoleWhat they receive
Olmesartan/Amlodipin fixed combinationExperimentalNot described
Receives: Drug: Candesartan cilexetil; Drug: Olmesartan/Amlodipin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement).

    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

    Measured: after six and after 12 weeks

  2. change in systolic OBPM

    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.

    Measured: after 6 and after 12 weeks

Secondary outcomes (6)

  1. change in diastolic OBPM

    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

    Measured: after six and after 12 weeks

  2. Change in systolic and diastolic ABPM night mean values

    first ABPM to be performed after 2 weeks wash-out followed by six weeks monotherapy with candesartan. Second ABPM to be performed after six weeks therapy with the fixed combination, given in the morning.

    Measured: after 6 weeks therapy with fixed combination of olmesartan and amlodipine

  3. change in 24 hr mean values and diastolic day mean value

    Measured: after six and after 12 weeks

  4. Distribution of patients over the four dipper types

    Measured: after six and after 12 weeks

  5. Number of patients achieving target values for OBPM and ABPM

    Measured: after six and after 12 weeks

  6. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: From screening visit to end of follow-up, up to 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2012 (estimated)
  2. Study startDec 2011
  3. Primary completionSep 2012
  4. Study completionOct 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01613209
Sponsor's protocol ID
Sevicontrol-1
Acronym
Sevicontrol1
Status last verified
May 2016
First submitted
30 May 2012
Last updated
3 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Candesartan cilexetil and Olmesartan/Amlodipin in people with Hypertension, run by Institut für Pharmakologie und Präventive Medizin at 12 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 1 inclusion and 17 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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 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?

Change in ABPM (ambulatory blood pressure measurement) mean daytime systolic values and change in systolic OBPM (office blood pressure measurement). (time frame: after six and after 12 weeks). The study lists 2 primary outcomes in all. 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 NCT01613209.

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 3 May 2016.

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