Amlodipine as add-on to Olmesartan in Hypertension
Sponsor
Sankyo Pharma Gmbh (Industry)
Overall Status
Completed
CT.gov ID
NCT00220220
Collaborator
(none)
429
6
24
71.5
3
Study Details
Study Description
Brief Summary
Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
429 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Amlodipine Used as add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy
Study Start Date
:
Apr 1, 2005
Actual Study Completion Date
:
Apr 1, 2007
Outcome Measures
Primary Outcome Measures
- Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment. []
Secondary Outcome Measures
- Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment. []
- Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment. []
- Safety and tolerability []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.
Exclusion Criteria:
-
Secondary hypertension of any aetiology;
-
Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
-
History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamburg | Germany | |||
| 2 | Magdeburg | Germany | |||
| 3 | Messkirch | Germany | |||
| 4 | Stuhr | Germany | |||
| 5 | Tann | Germany | |||
| 6 | Worpswede | Germany |
Sponsors and Collaborators
- Sankyo Pharma Gmbh
Investigators
- Principal Investigator: Peter Brommer, MD,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00220220
Other Study ID Numbers:
- CS8663-A-E302
First Posted:
Sep 22, 2005
Last Update Posted:
Dec 24, 2018
Last Verified:
Oct 1, 2007
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: