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Trial record 14 of 73 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients

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.
 
ClinicalTrials.gov Identifier: NCT00267943
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : November 13, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE December 21, 2005
First Posted Date  ICMJE December 22, 2005
Last Update Posted Date November 13, 2013
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
Proportion of patients achieving diastolic blood pressure (DBP) control 24 hours after last dose [ Time Frame: at 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP < 90 mmHg at trough i.e. 24 hours after last dose) at six months of treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2013)
  • Change from baseline in trough seated DBP. [ Time Frame: at 6 months ]
  • Change from baseline in trough seated systolic blood pressure (SBP) [ Time Frame: at 6 months ]
  • Proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg) [ Time Frame: at 6 months ]
  • Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg) [ Time Frame: at 6 months ]
  • Proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) [ Time Frame: at 6 months ]
  • Proportion of patients in the trough seated BP category optimal [ Time Frame: at 6 months ]
  • Proportion of patients in the trough seated BP category normal [ Time Frame: at 6 months ]
  • Proportion of patients in the trough seated BP category high-normal [ Time Frame: at 6 months ]
  • Proportion of patients in the trough seated BP category high [ Time Frame: at 6 months ]
  • Proportion of patients requiring additional antihypertensive therapy to achieve DBP control [ Time Frame: at 6 months ]
  • Additional reduction in BP by the use of additional antihypertensive therapy [ Time Frame: at 6 months ]
  • Time to starting additional antihypertensive therapy [ Time Frame: within 6 months ]
  • Incidence and intensity of Adverse events [ Time Frame: 6 month ]
  • Physical examinations [ Time Frame: 6 month ]
  • Change in laboratory parameters [ Time Frame: 6 month ]
  • 12-Lead Electrocardiogramm ECG [ Time Frame: 6 month ]
  • Vital Signs (pulse rate, SBP, DBP) [ Time Frame: 6 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
The secondary efficacy endpoint variables include a range of blood pressure measurements e.g. seated trough systolic blood pressure. Safety (vital signs, laboratory values, physical examination and ECG findings) will also be assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients
Official Title  ICMJE An Open-label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 80 mg + Hydrochlorothiazide 25 mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.
Brief Summary The primary objective is to assess the efficacy and safety of the fixed dose combination of telmisartan 80 mg + hydrochlorothiazide 25 mg (T80/H25) alone or in addition to other antihypertensive therapies during open-label, long-term treatment.
Detailed Description

Patients with a history of hypertension who completed a preceding trial (number 502.480) within the previous fourteen (14) days will be considered for entry to this long-term open-label trial. All patients will receive 'T80/H25'. Additional antihypertensive therapy will be allowed if the patients' blood pressure is not well controlled. [In the preceding double-blind trial 502.480, patients who failed to respond to the fixed dose combination of telmisartan 80 mg '+' hydrochlorothiazide 12.5 mg (T80/H12.5) were randomised to 'T80/H12.5' or T80H25 for eight weeks.] This is a multi-centre, multinational trial with approximately 80 study centres participating. Only study centres participating in the preceding trial 502.480 can enter patients into this open-label trial. It is anticipated that a maximum of 480 patients will be entered into the trial in seventeen countries. Each trial centre is expected to enter between four and twenty-four patients.

Enrollment of patients into this trial will finish when the last patient completes the preceding trial 502.480. At this time, centres will be notified of the termination of recruitment and will not be authorized to include any further patients.

Patients will visit the clinic one month, three months and six months later for assessment of their blood pressure and general health. Their participation in the study is complete six months after the start of the treatment period.

Study Hypothesis:

No statistical hypothesis will be tested. Descriptive statistics will be used to characterise the effects of treatment with T80/H25 with and without other antihypertensive treatments.

Comparison(s):

The proportion of patients achieving DBP control will be summarised by the total number of patients in the trial as well as by the maximum achieved dose level according to the two categories of T80/H25 alone (T80/H25) and with other antihypertensive medication added (T80/H25/other). An additional sub-group summary by the treatment group in the preceding trial 502.480 (T80/H12.5 and T80/H25) will also be presented.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: telmisartan 80 mg + hydrochlorothiazide 25 mg
Study Arms  ICMJE Not Provided
Publications * Neldam S, Edwards C. Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opin Pharmacother. 2009 Feb;10(3):345-52. doi: 10.1517/14656560802707937 .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: November 12, 2013)
639
Original Enrollment  ICMJE
 (submitted: December 21, 2005)
480
Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Essential hypertension.
  • Currently taking between one and three antihypertensive medications at a stable dose for at least four weeks before Visit 1 of preceding trial 502.480.
  • Blood pressure not adequately controlled on existing treatment before entry to preceding trial 502.480 (inadequate control defined as seated DBP >= 95 mmHg on one current antihypertensive medication or DBP >= 90 mmHg on two or more current antihypertensive medications).
  • Failure to respond to six weeks run-in treatment with T80/H12.5 in preceding trial 502.480. (Failure to respond defined as seated DBP >= 90 mmHg.)
  • Willing and able to provide written informed consent.

Exclusion criteria:

  • Women of child-bearing potential NOT practising acceptable means of birth control, positive serum pregnancy test, breastfeeding.
  • Known or suspected secondary hypertension.
  • Clinically significant change in ECG reported as adverse event in preceding trial 502.480.
  • Any medical condition developing in preceding trial 502.480 that could be worsened by telmisartan/HCTZ (80/25).
  • Discontinuation from preceding 502.480 trial for adverse event or any other reason.
  • Mean SBP >= 200 mmHg.
  • Severe hepatic or renal impairment.
  • Bilateral renal artery stenosis (or in a solitary kidney), post-renal transplant or only one functioning kidney.
  • Clinically relevant hypokalaemia or hyperkalaemia.
  • Uncorrected volume or sodium depletion, primary aldosteronism.
  • Hereditary fructose intolerance.
  • Previous symptoms of angioedema after ACE inhibitors or angiotensin-II receptor antagonists.
  • Drug or alcohol dependency within the six months prior to entry to 502.480. concurrent participation in another clinical trial or any investigational therapy.
  • Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
  • Allergic hypersensitivity to any component of the formulations under investigation.
  • Concomitant therapy with lithium, cholestyramine or colestipol resins.
  • Non-compliance with study medication (less than 80% or more than 120%) during the preceding 502.480 trial.
  • Any other clinical condition which, in the opinion of the investigator, would not allow safe administration of telmisartan or hydrochlorothiazide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Finland,   France,   Germany,   Hong Kong,   Ireland,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   Norway,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT00267943
Other Study ID Numbers  ICMJE 502.491
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator BIL UK / Ireland
PRS Account Boehringer Ingelheim
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP