Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose
This study has been completed.
Information provided by:
Boehringer Ingelheim Pharmaceuticals
First received: May 2, 2002
Last updated: October 31, 2013
Last verified: October 2013
The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
Drug: telmisartan, valsartan
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (Telmisartan 80 mg p.o. Once Daily) and Diovan® (Valsartan 160 mg p.o. Once Daily) Using Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Hypertension After Missing One Dose
Primary Outcome Measures:
- Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose [ Time Frame: after 6 to 8 weeks ] [ Designated as safety issue: No ]
- Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication [ Time Frame: after 6 to 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose [ Time Frame: after 6 to 8 weeks ] [ Designated as safety issue: No ]
- Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment [ Time Frame: after 6 to 8 weeks ] [ Designated as safety issue: No ]
- Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Responder rates based on ABPM [ Time Frame: after 6 to 8 weeks ] [ Designated as safety issue: No ]
- Responder rates based on in-clinic trough cuff blood pressures [ Time Frame: after 6 to 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||August 2002 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
1. Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP of greater than or equal to 85 mm Hg.
Pre-menopausal women (last menstruation = 1 year prior to signing informed consent) who:
- Are not surgically sterile.
- Are nursing.
- Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. No exceptions will be made.
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
- Known or suspected secondary hypertension (i.e., pheochromocytoma).
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range.
- 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.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Biliary obstructive disorders.
- Congestive heart failure (NYHA functional class CHF III-IV).
- Unstable angina within the past three months prior to signing the informed consent form.
- Stroke within the past six months prior to signing the informed consent form.
- Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
- PTCA (percutaneous transluminal coronary revascularization) within the past three months prior to signing the informed consent form.
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
- Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C =10%.
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
- History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
- Any investigational therapy within one month of signing the informed consent form.
- Known hypersensitivity to any component of the formulations.
- Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
- Inability to comply with the protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034840
Boehringer Ingelheim Pharmaceuticals
||Boehringer Ingelheim Study Coordinator
||Boehringer Ingelheim Pharmaceuticals
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2002
||October 31, 2013
||United States: Food and Drug Administration
Keywords provided by Boehringer Ingelheim Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors