Clinical trial NCT02177422: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Achievement of goal blood pressure response defined by a mean sitting diastolic blood pressure <90 mmHg
timeFrame: Up to one year
measure: Need for addition of hydrochlorothiazide or subsequent change in antihypertensive therapy
timeFrame: Up to one year
measure: Time to addition of hydrochlorothiazide or any subsequent change in antihypertensive therapy
timeFrame: Up to one year
measure: Mean sitting diastolic blood pressure during each visit
timeFrame: At months 3, 6, 9, 12
measure: Mean sitting systolic blood pressure during each visit
timeFrame: At months 3, 6, 9, 12
measure: Number of patient with adverse events
timeFrame: Up to one year
measure: Changes from baseline in heart rate
timeFrame: Baseline and at months 3, 6, 9, 12
measure: Number of patients with abnormal changes in 12-Lead ECG (electrocardiogram)
timeFrame: Baseline and 12 months
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: Baseline and 12 months
measure: Number of patients with abnormal findings in physical examination
timeFrame: Baseline and at 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: