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Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine (Sevicontrol1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier:
NCT01613209
First received: May 30, 2012
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Candesartan cilexetil
Drug: Olmesartan/Amlodipin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Institut für Pharmakologie und Präventive Medizin:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

  • change in systolic OBPM [ Time Frame: after 6 and after 12 weeks ] [ Designated as safety issue: Yes ]
    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan: change in systolic OPM.


Secondary Outcome Measures:
  • change in diastolic OBPM [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
    After 6 weeks therapy with a fixed combination of olmesartan and amlodipine compared to monotherapy with candesartan

  • Change in systolic and diastolic ABPM night mean values [ Time Frame: after 6 weeks therapy with fixed combination of olmesartan and amlodipine ] [ Designated as safety issue: No ]
    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.

  • change in 24 hr mean values and diastolic day mean value [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
  • Distribution of patients over the four dipper types [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
  • Number of patients achieving target values for OBPM and ABPM [ Time Frame: after six and after 12 weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: From screening visit to end of follow-up, up to 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olmesartan/Amlodipin fixed combination Drug: Candesartan cilexetil
candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,
Drug: Olmesartan/Amlodipin
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)
Other Name: Sevikar(r)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613209

Locations
Germany
Praxis Dr. Loddo
Rastede, Niedersachsen, Germany, 26180
Praxis Dr. Paschmionka
Leipzig, Sachsen, Germany, 04316
Praxis Dr. Reimer
Anderbeck, Germany, 38836
Praxis Dr. Heinz
Bergisch-Gladbach, Germany, 51429
Praxis Dr. Zemmrich
Berlin, Germany, 12043
Praxis Dr. Biedermann
Blankenhain, Germany, 99444
St.-Josefs-Hospital
Cloppenburg, Germany, 49661
Praxis Dr. Pohl
Dresden, Germany, 01129
Praxis Koßler-Wiesweg
Essen, Germany, 45138
Praxis Dr. Rövenich
Frankfurt, Germany, 65929
Praxis Dr. Strzata
Kapellendorf, Germany, 99510
Praxis Dr. Pitule
Ludwigshafen, Germany, 67061
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Investigators
Principal Investigator: Stephan Lueders, Dr.med. Krankenhaus St.-Josef-Stift, Krankenhausstraße 13, D-49661 Cloppenburg
  More Information

No publications provided

Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT01613209     History of Changes
Other Study ID Numbers: Sevicontrol-1
Study First Received: May 30, 2012
Last Updated: June 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Pharmakologie und Präventive Medizin:
Hypertension
ABPM
office blood pressure
olmesartan
amlodipine
fixed combination
time of intake

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Amlodipine
Candesartan
Candesartan cilexetil
Olmesartan
Olmesartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014