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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Hydrochlorothiazide

• Registration Number: NCT02177422
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-06
• Primary Completion: 1999-11
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-07
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan	Telmisartan	-
Telmisartan	Hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg	Up to one year
Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy	Up to one year
Mean sitting systolic blood pressure during each visit	At months 3, 6, 9, 12
Number of patient with adverse events	Up to one year
Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy	Up to one year
Mean sitting diastolic blood pressure during each visit	At months 3, 6, 9, 12
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