An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
1 other identifier
interventional
259
1 country
7
Brief Summary
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy
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
7 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
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 8, 2008
CompletedFirst Posted
Study publicly available on registry
February 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedResults Posted
Study results publicly available
March 3, 2010
CompletedJune 27, 2014
April 1, 2014
1.8 years
February 8, 2008
December 28, 2009
June 17, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Experienced Adverse Events
An adverse event is defined as any untoward medical occurrence
52 weeks
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
First administration of study treatment to 24 hours post last dosing of study treatment.
Secondary Outcomes (11)
Change From Baseline in Seated Diastolic Blood Pressure at Week 8
Baseline and week 8
Change From Baseline in Seated Systolic Blood Pressure at Week 8
Baseline and week 8
Seated DBP Control Rate at Trough After 8 Weeks
week 8
Seated SBP Control Rate at Trough After 8 Weeks
Week 8
Change From Baseline in Seated Diastolic Blood Pressure
Baseline and week 20 / week 48
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Patients with essential hypertension
- Outpatient
You may not qualify if:
- Patients whose SBP \>=180 mmHg or DBP \>=110 mmHg at the end of treatment visit of the double-blind treatment period in the "non-responder trials"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
1235.16.004 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan
1235.16.006 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
1235.16.005 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.003 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.16.001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1235.16.002 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
MeSH Terms
Conditions
Condition 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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 8, 2008
First Posted
February 20, 2008
Study Start
January 1, 2008
Primary Completion
October 1, 2009
Last Updated
June 27, 2014
Results First Posted
March 3, 2010
Record last verified: 2014-04