PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Telmisartan

Drug: Ramipril

Study type

Interventional

Funder types

Industry

Identifiers

NCT00274599

502.392

Details and patient eligibility

About

Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.

Enrollment

812 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥95 mmHg and ≤109 mmHg, measured by manual cuff sphygmomanometer at Visit 2.
Age 18 years or older (or 19 years if dictated by local State/Province policies).
Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
24-hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM).

Exclusion criteria

Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
- were not surgically sterile; or
- were nursing, or
- were of childbearing potential and were NOT practicing acceptable methods of birth control, or did NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control included IUD, oral, implantable or injectable contraceptives. No exceptions were made.
Night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m.
Mean seated SBP ≥180 mmHg or mean seated DBP ≥110 mmHg during any visit of the placebo run-in period.
Known or suspected secondary hypertension (e.g., phaeochromocytoma).
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) or Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) >2 times the upper limit of normal range, or
Serum creatinine >2.3 mg/dL (or >203 μmol/l).
Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
Uncorrected volume depletion.
Further exclusion criteria apply