- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260089
Telmisartan in Mild to Moderate Hypertensive Patients
October 8, 2014 updated by: Boehringer Ingelheim
A Multicenter Open-label Study of the Efficacy and Safety of Telmisartan in Mild to Moderate Hypertensive Patients
To evaluate the efficacy and tolerability of telmisartan, given once a day to patients with mild to moderate hypertension, as well as to assess the 24-hour blood pressure profile with ABPM
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with blood pressure levels of 140/90 mm Hg or higher (confirmed on 2 consecutive visits), who were 18 years old and older, regardless of sex
Exclusion Criteria:
- Suspected or known diagnosis of arterial hypertension with a secondary cause
- Women who were not using an effective method of contraception, or who were pregnant, or breast-feeding
- Systolic blood pressure > 200 mm Hg or diastolic blood pressure > 115 mm Hg
- Laboratory test values two fold above the upper normal limit
- Previous intolerance to angiotensin conversion enzyme inhibitors or angiotensin II blocker (AIIAR)
- New York Heart Association class III or IV heart failure
- History of stroke in the 6 months prior to entry into the study
- Uncontrolled type 2 diabetes mellitus, defined as fasting glucose levels > 140 mg/dL on 3 consecutive assessments
- Patients who were included in another investigational drug study in the past 30 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low dose of telmisartan
4 week placebo run-in phase followed by 6 weeks of treatment with low dose of telmisartan
|
|
EXPERIMENTAL: High dose of telmisartan
After 6 weeks of treatment with low dose of telmisartan, titration to high dose of telmisartan if blood pressure level is higher than 140/90 mm Hg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Time Frame: Baseline, up to 12 weeks after start of treatment
|
Blood pressure values were obtained 24 hours after the last dose (through values) at the office
|
Baseline, up to 12 weeks after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of treatment response for SBP/DBP (in %)
Time Frame: Baseline, up to 12 weeks after start of treatment
|
Response categories:
|
Baseline, up to 12 weeks after start of treatment
|
Changes from baseline in blood pressure values
Time Frame: Baseline, up to 12 weeks after start of treatment
|
Analysis performed for the ambulatory blood pressure monitoring (ABPM) - subgroup
|
Baseline, up to 12 weeks after start of treatment
|
Number of patients with adverse events
Time Frame: Up to 16 weeks
|
Up to 16 weeks
|
|
Number of patients with clinically significant changes in laboratory values
Time Frame: Up to 16 weeks
|
Up to 16 weeks
|
|
Number of patients with clinically significant changes in ECG
Time Frame: Up to 16 weeks
|
Up to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2000
Primary Completion (ACTUAL)
July 1, 2002
Study Registration Dates
First Submitted
October 8, 2014
First Submitted That Met QC Criteria
October 8, 2014
First Posted (ESTIMATE)
October 9, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
October 9, 2014
Last Update Submitted That Met QC Criteria
October 8, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 502.363
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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