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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

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ClinicalTrials.gov Identifier: NCT00168779
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 28, 2017
Sponsor:
Information provided by:
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: telmisartan 80 mg / hydrochlorothiazide 25 mg Drug: valsartan 160 mg / hydrochlorothiazide 25 mg Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1185 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official 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.
Study Start Date : September 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Mean seated trough cuff DBP and SBP [ Time Frame: after 8 week ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pre-menopausal women (last menstruation ? 1 year prior to start of run-in period) who:

    1. are not surgically sterile and/or
    2. are nursing or pregnant
    3. 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).
  2. Known or suspected secondary hypertension.
  3. Mean seated SBP >= 180 mmHg or mean seated DBP >= 120 mmHg during any clinic visit prior to randomization.
  4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    1. SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range, or
    2. Serum creatinine > 3.0 mg/dL or creatinine clearance < 0.6 ml/sec.
  5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney.
  6. Clinically relevant hypokalemia or hyperkalemia.
  7. Uncorrected volume depletion.
  8. Uncorrected sodium depletion.
  9. Primary aldosteronism.
  10. Hereditary fructose intolerance.
  11. Biliary obstructive disorders, cholestatis or moderate to severe hepatic in sufficiency.
  12. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
  13. History of drug or alcohol dependency within six months prior to start of run-in period.
  14. Chronic administration of any medications known to affect blood pressure, exc

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168779


  Show 113 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00168779     History of Changes
Other Study ID Numbers: 502.476
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators