Randomized, Double-Blind, Placebo-Controlled, Forced-Titration, Comparing Telmisartan vs Valsartan. Taken Orally for Eight Weeks in Patients With Stage 1 and Stage 2 Hypertension

Completed · Phase 4 · Has a placebo group

Conditions studied: Hypertension

In brief

The primary objective of this study is to compare the effectiveness of telmisartan 80 mg / hydrochlorothiazide 25 mg \[Micardis HCT\] to valsartan 160 mg / hydrochlorothiazide 25 mg \[Diovan HCT\] and placebo in the treatment of Stage 1 and Stage 2 hypertension.

Key facts

Study ID

NCT00168779

Run by

Boehringer Ingelheim

People needed

1185

Starts

2005-09-01

Expected to finish

2006-07-01

Last updated by the study team

2017-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide written informed consent.
• Age 18 years or older
• Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
• Seated cuff DBP of ? 95 mmHg at Visit 2 (baseline)

You may not qualify if…

• Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:
• are not surgically sterile and/or
• are nursing or pregnant
• are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of > 3-months duration. Acceptable methods of birth control include oral, implantable, transdermal, or injectable contraceptives, and Intra-Uterine Device (IUD).
• Known or suspected secondary hypertension.
• Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.
• 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, or
• Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
• Clinically relevant hypokalemia or hyperkalemia.
• Uncorrected volume depletion.
• Uncorrected sodium depletion.
• Primary aldosteronism.
• Hereditary fructose intolerance.
• Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
• 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 six months prior to start of run-in period.
• Chronic administration of any medications known to affect blood pressure, exc

Where it is running

• 502.476.059 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 502.476.071 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 502.476.079 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 502.476.014 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 502.476.031 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 502.476.110 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 502.476.037 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 502.476.061 Boehringer Ingelheim Investigational Site — Glendale, Arizona, United States
• 502.476.066 Boehringer Ingelheim Investigational Site — Carlisle, Arkansas, United States
• 502.476.067 Boehringer Ingelheim Investigational Site — Buena Park, California, United States
• 502.476.086 Boehringer Ingelheim Investigational Site — Encinitas, California, United States
• 502.476.124 Boehringer Ingelheim Investigational Site — Greenbrae, California, United States
• 502.476.005 Boehringer Ingelheim Investigational Site — Long Beach, California, United States
• 502.476.024 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 502.476.029 Boehringer Ingelheim Investigational Site — Redondo Beach, California, United States
• 502.476.048 Boehringer Ingelheim Investigational Site — Riverside, California, United States
• 502.476.073 Boehringer Ingelheim Investigational Site — Sacramento, California, United States
• 502.476.087 Boehringer Ingelheim Investigational Site — San Diego, California, United States
• 502.476.111 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
• 502.476.050 Boehringer Ingelheim Investigational Site — Santa Ana, California, United States
• 502.476.026 Boehringer Ingelheim Investigational Site — Spring Valley, California, United States
• 502.476.033 Boehringer Ingelheim Investigational Site — Tulsa, California, United States
• 502.476.019 Boehringer Ingelheim Investigational Site — Boulder, Colorado, United States
• 502.476.101 Boehringer Ingelheim Investigational Site — Highlands Ranch, Colorado, United States
• 502.476.074 Boehringer Ingelheim Investigational Site — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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