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Safety Evaluation of Telmisartan Plus Hydrochlorothiazide in Patients With Mild-to-Moderate Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02177487
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to assess the safety of six month of open-label, treatment with the fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients with mild-to-moderate hypertension who completed the eight week randomized, double blind 502.261 study.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Telmisartan/hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Six Month Safety Evaluation of the Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg in Patients With Mild-to-Moderate Hypertension
Study Start Date : June 1999
Actual Primary Completion Date : January 2000

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telmisartan + Hydrochlorothiazide Drug: Telmisartan/hydrochlorothiazide

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 6 months ]
  2. Changes from baseline in laboratory tests [ Time Frame: Baseline and month 6 ]
  3. Changes from baseline in physical examination [ Time Frame: Baseline and month 6 ]
  4. Changes from baseline in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline and month 6 ]
  5. Changes from baseline in seated blood pressure [ Time Frame: Baseline, month 1, 3 and 6 ]
  6. Changes from baseline in pulse rate [ Time Frame: Baseline, month 1, 3 and 6 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients who were randomized and completed all study visits of the preceding double-blind trial with the fixed dose combination (502.261) who meet the following criteria:

    • Patients that are not controlled on telmisartan 80 mg monotherapy at the final visit (Visit 6) of the 502.261 study
  • Patients who are able to provide written informed consent
  • Patients who are able to enter the study immediately upon their completion of the preceding double-blind trial of the fixed dose combination (502.261)

Exclusion Criteria:

  • Patients with any exclusion criterion (except criteria 1, 19 and 20), as defined in the preceding study (502.261):

    • Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening)

      • who are not surgically sterile (hysterectomy, tubal ligation)
      • who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device (IUD), oral, implantable or injectable contraceptives
    • Any women:

      • who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
      • who has a positive urine pregnancy test prior to taking the first dose of open-label medication (at Visit 2)
      • who is nursing
    • Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

      • SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
      • Serum creatinine > 2.3 mg/dL
    • Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
    • Known or suspected secondary hypertension
    • Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
    • Congestive heart failure (CHF) (NYHA (New York Heart Association) class CHF III-IV)
    • Unstable angina within the past three months
    • Stroke within the past six months
    • Myocardial infarction or cardiac surgery within the past three months
    • PTCA (percutaneous transluminal coronary angioplasty) within the past three months
    • History of angioedema
    • 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
    • Administration of digoxin or other digitalis-type drugs
    • Patients with insulin treated Type II diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
    • Known drug or alcohol dependency within the past one year period
    • 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

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Responsible Party: Boehringer Ingelheim Identifier: NCT02177487     History of Changes
Other Study ID Numbers: 502.321
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists