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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Hydrochlorothiazide; Drug: Telmisartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02177422

502.260

Details and patient eligibility

About

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.

Enrollment: 489 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

489 participants in 1 patient group

Telmisartan

Experimental group

Treatment:

Drug: Hydrochlorothiazide

Drug: Telmisartan