Back to resultsEfficacy and Safety of Telmisartan and Losartan in Primary Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Low dose of telmisartan
High dose of telmisartan
Low dose of losartan
High dose of losartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and < 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) < 180 mmHg
Exclusion Criteria:
- Not specified
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telmisartan
Losartan
Arm Description
Low dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered
Low dose of losartan, uptitrated to high dose in case no sufficient effect is observered
Outcomes
Primary Outcome Measures
Changes in mean sitting valley value of DBP
The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives
Secondary Outcome Measures
Full Information
NCT ID
NCT02269176
First Posted
October 20, 2014
Last Updated
October 20, 2014
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02269176
Brief Title
Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension
Official Title
12 Week, Multi-center, Randomized, Double-blind, Double Dummy, Parallel Group Trial Comparing the Efficacy and Safety of 40 & 80 mg Telmisartan and 50 & 100 mg Losartan in the Treatment of 150 Pairs of Primary Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Using Losartan as a comparator, to evaluate the efficacy and safety of telmisartan in the treatment of the mild to moderate primary hypertension patients in China
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Low dose of telmisartan, uptitrated to high dose in case no sufficient effect is observered
Arm Title
Losartan
Arm Type
Active Comparator
Arm Description
Low dose of losartan, uptitrated to high dose in case no sufficient effect is observered
Intervention Type
Drug
Intervention Name(s)
Low dose of telmisartan
Intervention Type
Drug
Intervention Name(s)
High dose of telmisartan
Intervention Type
Drug
Intervention Name(s)
Low dose of losartan
Intervention Type
Drug
Intervention Name(s)
High dose of losartan
Primary Outcome Measure Information:
Title
Changes in mean sitting valley value of DBP
Description
The valley value of blood pressure refers to the blood pressure measured prior to the next administration of antihypertensives
Time Frame
8 weeks after start of treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate primary hypertension, the mean sitting valley value of diastolic blood pressure (DBP) ≥ 95 and < 110 mmHg, and the mean sitting valley value of systolic blood pressure (SBP) < 180 mmHg
Exclusion Criteria:
- Not specified
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info
Learn more about this trial
Efficacy and Safety of Telmisartan and Losartan in Primary Hypertension
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