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

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00274599

Run by

Boehringer Ingelheim

People needed

812

Starts

2002-10-09

Last updated by the study team

2023-12-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
• Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• Harold B. Betton, M.D. — Little Rock, Arkansas, United States
• Attn: Ginger Paselk — Long Beach, California, United States
• Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• Boehringer Ingelheim Investigational Site — Orange, California, United States
• Boehringer Ingelheim Investigational Site — San Diego, California, United States
• Boehringer Ingelheim Investigational Site — Santa Ana, California, United States
• Boehringer Ingelheim Investigational Site — Santa Rosa, California, United States
• Boehringer Ingelheim Investigational Site — Vista, California, United States
• Boehringer Ingelheim Investigational Site — Hamden, Connecticut, United States
• Boehringer Ingelheim Investigational Site — Daytona Beach, Florida, United States
• Boehringer Ingelheim Investigational Site — Fort Lauderdale, Florida, United States
• Boehringer Ingelheim Investigational Site — Melbourne, Florida, United States
• Boehringer Ingelheim Investigational Site — Marietta, Georgia, United States
• Boehringer Ingelheim Investigational Site — Boise, Idaho, United States
• Boehringer Ingelheim Investigational Site — Meridian, Idaho, United States
• Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
• Boehringer Ingelheim Investigational Site — Orland Park, Illinois, United States
• GFI Pharmaceuticals — Evansville, Indiana, United States
• Boehringer Ingelheim Investigational Site — Newton, Kansas, United States
• Boehringer Ingelheim Investigational Site — Wichita, Kansas, United States
• Boehringer Ingelheim Investigational Site — Metairie, Louisiana, United States
• Boehringer Ingelheim Investigational Site — Auburn, Maine, United States
• Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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