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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 489
- Primary Endpoint
- Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Telmisartan
Intervention: Telmisartan (Drug)
Telmisartan
Intervention: Hydrochlorothiazide (Drug)
Outcomes
Primary Outcomes
Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg
Time Frame: Up to one year
Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy
Time Frame: Up to one year
Mean sitting systolic blood pressure during each visit
Time Frame: At months 3, 6, 9, 12
Number of patient with adverse events
Time Frame: Up to one year
Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy
Time Frame: Up to one year
Mean sitting diastolic blood pressure during each visit
Time Frame: At months 3, 6, 9, 12
Changes from baseline in heart rate
Time Frame: Baseline and at months 3, 6, 9, 12
Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram)
Time Frame: Baseline and 12 months
Number of patients with abnormal changes in laboratory parameters
Time Frame: Baseline and 12 months
Number of patients with abnormal findings in physical examination
Time Frame: Baseline and at 12 month
Secondary Outcomes
No secondary outcomes reported