An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy
8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
1 other identifier
interventional
324
3 countries
16
Brief Summary
The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedResults Posted
Study results publicly available
September 20, 2012
CompletedJune 27, 2014
December 1, 2013
1.1 years
April 13, 2010
August 21, 2012
June 17, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in DBP After 8 Weeks of Treatment
Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Baseline and 8 weeks
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
Baseline and 8 weeks
Secondary Outcomes (8)
Change From Baseline in SBP After 8 Weeks of Treatment
Baseline and 8 weeks
DBP and SBP Control and Response After 8 Weeks of Treatment
Baseline and 8 weeks
Number of Patients in Blood Pressure Categories Over Time
8 weeks
Change From Baseline in DBP After 4 Weeks of Treatment
Baseline and 4 weeks
Change From Baseline in SBP After 4 Weeks of Treatment
Baseline and 4 weeks
- +3 more secondary outcomes
Study Arms (2)
Telmisartan80mg+Amlodipine5mg
EXPERIMENTALcombination therapy
amlodipine 5 mg
ACTIVE COMPARATORMonotherapy
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of essential hypertension
- failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
- provision of written informed consent
You may not qualify if:
- \. clinical conditions which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine for the planned duration of this trial (e.g. populations where labeling of either product recommends against its utilization)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
1235.29.86001 Boehringer Ingelheim Investigational Site
Beijing, China
1235.29.86004 Boehringer Ingelheim Investigational Site
Beijing, China
1235.29.86006 Boehringer Ingelheim Investigational Site
Changchun, China
1235.29.86013 Boehringer Ingelheim Investigational Site
Changsha, China
1235.29.86014 Boehringer Ingelheim Investigational Site
Guangzhou, China
1235.29.86012 Boehringer Ingelheim Investigational Site
Hangzhou, China
1235.29.86002 Boehringer Ingelheim Investigational Site
Shanghai, China
1235.29.86009 Boehringer Ingelheim Investigational Site
Shanghai, China
1235.29.86010 Boehringer Ingelheim Investigational Site
Shanghai, China
1235.29.86011 Boehringer Ingelheim Investigational Site
Shanghai, China
1235.29.86007 Boehringer Ingelheim Investigational Site
Shenyang, China
1235.29.86008 Boehringer Ingelheim Investigational Site
Tianjin, China
1235.29.60017 Boehringer Ingelheim Investigational Site
Johor Bahru, Malaysia
1235.29.60016 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
1235.29.63018 Boehringer Ingelheim Investigational Site
Metro Manila, Philippines
1235.29.63019 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
Related Publications (1)
Zhu D, Gao P, Holtbruegge W, Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014 Feb;42(1):52-66. doi: 10.1177/0300060513503756. Epub 2014 Jan 3.
PMID: 24391142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 15, 2010
Study Start
July 1, 2010
Primary Completion
August 1, 2011
Last Updated
June 27, 2014
Results First Posted
September 20, 2012
Record last verified: 2013-12