Sevicontrol-1: Efficacy and Safety of a Fixed Combination of Olmesartan/ Amlodipine (Sevicontrol1)
This study is currently recruiting participants.
Verified June 2012 by Institut für Pharmakologie und Präventive Medizin
Sponsor:
Institut für Pharmakologie und Präventive Medizin
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier:
NCT01613209
First received: May 30, 2012
Last updated: June 4, 2012
Last verified: June 2012
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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:
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Amlodipine
Amlodipine besylate
Candesartan
Olmesartan
Olmesartan medoxomil
Candesartan cilexetil
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 81 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613209
Contacts
| Contact: Peter Bramlage, PD Dr.med. | +49(0)33793147890 | peter.bramlage@ippmed.de |
| Contact: Stephan Lüders, Dr.med. | +49(0)4471-161930 | s.lueders@kh-clp.de |
Locations
| Germany | |
| Praxis Dr. Loddo | Recruiting |
| Rastede, Niedersachsen, Germany, 26180 | |
| Contact: Marco Loddo, Dr.med. +4944022532 | |
| Principal Investigator: Marco Loddo, Dr.med. | |
| Praxis Dr. Paschmionka | Recruiting |
| Leipzig, Sachsen, Germany, 04316 | |
| Contact: Rita Paschmionka, Dr.med. +493416517149 | |
| Principal Investigator: Rita Paschmionka, Dr. med. | |
| Praxis Dr. Reimer | Recruiting |
| Anderbeck, Germany, 38836 | |
| Contact: Cornelia Reimer, Dr.med. +4939422449 | |
| Principal Investigator: Cornelia Reimer, Dr.med. | |
| Praxis Dr. Heinz | Recruiting |
| Bergisch-Gladbach, Germany, 51429 | |
| Contact: Gerd-Ulrich Heinz, Dr.med. +492204911010 | |
| Principal Investigator: Gerd-Ulrich Heinz, Dr.med. | |
| Praxis Dr. Zemmrich | Recruiting |
| Berlin, Germany, 12043 | |
| Contact: Claudia Zemmrich, Dr.med. +491787152405 | |
| Principal Investigator: Claudia Zemmrich, Dr.med. | |
| Praxis Dr. Biedermann | Recruiting |
| Blankenhain, Germany, 99444 | |
| Contact: Annette Biedermann, Dr.med. +493645940703 | |
| Principal Investigator: Annette Biedermann, Dr.med. | |
| St.-Josefs-Hospital | Recruiting |
| Cloppenburg, Germany, 49661 | |
| Contact: Stephan Lüders, Dr.med. +494771161930 | |
| Principal Investigator: Stephan Lüders, Dr.med. | |
| Praxis Dr. Pohl | Recruiting |
| Dresden, Germany, 01129 | |
| Contact: Wilgard Pohl, Dr. med. +493518014052 | |
| Principal Investigator: Wilgard Pohl, Dr. med. | |
| Praxis Koßler-Wiesweg | Recruiting |
| Essen, Germany, 45138 | |
| Contact: Christine Koßler-Wiesweg, Dr.med. +49201282008 | |
| Principal Investigator: Bernd Wiedeking, Dr.med. | |
| Praxis Dr. Rövenich | Recruiting |
| Frankfurt, Germany, 65929 | |
| Contact: Mathias Rövenich, Dr.med. +4969302308 | |
| Principal Investigator: Mathias Rövenich, Dr.med. | |
| Praxis Dr. Strzata | Recruiting |
| Kapellendorf, Germany, 99510 | |
| Contact: Norbert Strzata, Dr.med. +493642553535 | |
| Principal Investigator: Norbert Strzata, Dr.med. | |
| Praxis Dr. Pitule | Recruiting |
| Ludwigshafen, Germany, 67061 | |
| Contact: Hannelore Pitule, Dr.med. +49621571317 | |
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 4, 2012 |
| 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 Vascular Diseases Cardiovascular Diseases Amlodipine Candesartan cilexetil Candesartan Olmesartan medoxomil Olmesartan Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013