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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Telmisartan
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telmisartan<br> | Drug: Telmisartan<br>* telmisartan 80 mg once daily<br>Drug: Hydrochlorothiazide<br>* 12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure < 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg |  | Up to one year | 
| Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy |  | Up to one year | 
| Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy |  | Up to one year | 
| Mean sitting diastolic blood pressure during each visit |  | At months 3, 6, 9, 12 | 
| Mean sitting systolic blood pressure during each visit |  | At months 3, 6, 9, 12 | 
| Number of patient with adverse events |  | Up to one year | 
| Changes from baseline in heart rate |  | Baseline and at months 3, 6, 9, 12 | 
| Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram) |  | Baseline and 12 months | 
| Number of patients with abnormal changes in laboratory parameters |  | Baseline and 12 months | 
| Number of patients with abnormal findings in physical examination |  | Baseline and at 12 month |