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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan; Drug: Hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Actual): 489
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan	Drug: Telmisartan; telmisartan 80 mg once daily; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 1998
• Primary Completion (Actual): November 1, 1999

Study Registration Dates

• First Submitted: June 26, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Telmisartan
• Other Study ID Numbers: 502.260