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

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

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: 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 mmHg

Need 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

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

Starting date: June 1998
Last updated: July 7, 2014