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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Telmisartan/hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

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 design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence of adverse events

Changes from baseline in laboratory tests

Changes from baseline in physical examination

Changes from baseline in 12-lead ECG (electrocardiogram)

Changes from baseline in seated blood pressure

Changes from baseline in pulse rate

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: June 1999
Last updated: July 7, 2014

Page last updated: August 23, 2015

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