Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Telmisartan (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim
Summary
The primary objective of this trial was to assess the efficacy and safety of telmisartan 80
mg during open-label, long-term treatment. An additional objective was to assess the
efficacy and safety of concomitant administration of telmisartan 80 mg and HCTZ
(Hydrochlorothiazide) and/or any other therapies commonly used in the treatment of
hypertension.
Clinical Details
Official title: Open-Label Follow-up Trial on Efficacy and Safety of Chronic Administration of Telmisartan 80 mg (Micardis®) Tablets as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension
Study design: Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHgNeed for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy Mean sitting diastolic blood pressure during each visit Mean sitting systolic blood pressure during each visit Number of patient with adverse events Changes from baseline in heart rate Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram) Number of patients with abnormal changes in laboratory parameters Number of patients with abnormal findings in physical examination
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who have met the inclusion criteria for the preceding clinical trial of
telmisartan. All patients must give a separate written informed consent for
participation in the open-label follow-up.
- Mild-to-moderate essential hypertension defined as a mean seated diastolic blood
pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer
- Mean seated systolic blood pressure ≥ 140 mmHg, measured my manual cuff
- A 24-hour mean diastolic blood pressure, measured by ABPM (ambulatory blood
pressure measurement), of ≥ 85 mmHg
- Age 18 or older
- Patient's written informed consent in accordance with GCP (Good Clinical
Practice) and local legislation
Exclusion Criteria:
- Patients with a clinically significant change in ECG from baseline that was reported
as an adverse event during the preceding clinical trial
- Patients who have developed a medical condition during the preceding clinical trial
that, in the investigator's opinion, may be worsened by treatment or may compromise
the safety evaluation of telmisartan
- Patients who discontinued the preceding telmisartan clinical trial due to an adverse
event
- Any other clinical condition which, in the opinion of the investigator, would not
allow safe completion of the protocol and safe administration of telmisartan
Locations and Contacts
Additional Information
Starting date: June 1998
Last updated: July 7, 2014
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