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Completed

NCT Number: NCT00168779

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

502.476.074 Boehringer Ingelheim Investigational Site, Athens, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

telmisartan 80 mg / hydrochlorothiazide 25 mg

Drug

valsartan 160 mg / hydrochlorothiazide 25 mg

Drug

Placebo

Drug

Primary outcomes

  1. Mean seated trough cuff DBP and SBP

    Time frame: after 8 week

Secondary outcomes

  1. The percentage of patients responding to treatment based on in-clinic mean seated trough cuff measurements

    Time frame: after 8 week

  2. The percentage of patients with uncontrolled hypertension

    Time frame: after 8 weeks

  3. Change in the in-clinic mean seated cuff DBP and SBP at the one and three hour post dose time points

    Time frame: after 8 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Forced-titration, Phase IV Study Comparing Telmisartan 80 mg + Hydrochlorothiazide 25 mg Versus Valsartan 160 mg + Hydrochlorothiazide 25 mg Taken Orally for Eight Weeks in Patients With Stage 1 or Stage 2 Hypertension.

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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