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

NCT ID: NCT02177422

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 489 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30

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.

Conditions

Hypertension

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telmisartan

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

telmisartan 80 mg once daily

Hydrochlorothiazide

Intervention Type: DRUG

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

Interventions

Telmisartan

telmisartan 80 mg once daily

Intervention Type: DRUG

Hydrochlorothiazide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.260

Identifier Type: -

Identifier Source: org_study_id