Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension

July 7, 2014 updated by: Boehringer Ingelheim

A Prospective Randomised Open-Label Blinded Endpoint Trial Comparing Telmisartan 80 mg and Losartan 50 mg + Hydrochlorothiazide 12.5 mg (Fixed Dose Combination) in Patients With Mild-to-Moderate Essential Hypertension Using Ambulatory Blood Pressure Monitoring

The general aim and clinical objective of this trial is to determine the effect of telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff measurements at the end of the treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
715

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline)
  • Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2)
  • A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3)
  • Age 18 or older
  • Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

Exclusion Criteria:

  • Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):

    • Who are not surgically sterile (hysterectomy, tubal ligation)
    • Who are NOT practising acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the trial. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives
    • Who have a positive urine pregnancy test
    • Who are nursing
  • Mean seated diastolic blood pressure (DBP) > 114 mmHg or mean seated systolic BP > 200 mmHg, by manual cuff

  • Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters:

    • SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate oxaloacetate transaminase) (AST) greater than two times the upper limit of normal
    • Serum creatinine > 1.8 mg/dl (or 159 µmol/l)
  • Clinically relevant hypokalemia
  • Known or suspected secondary hypertension
  • Known 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 3 months; stable angina where a change in nitrate therapy (dose or frequency) during the run-in period was required
  • Stroke within the past 6 months prior to start of run-in period
  • Myocardial infarction or cardiac surgery within the past 3 months prior to start of run-in period
  • PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to start of run-in period
  • Previous history of angioedema
  • Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
  • Hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve
  • Patients with unstable insulin-dependent diabetes mellitus (risk of hypoglycemia or HbA1c ≥ 10 % in history within 6 months prior to start of run-in period)
  • Known drug or alcohol dependency within the past 6 months period prior to start of run-in period
  • Concomitant administration of medications known to affect blood pressure, except medications allowed by the protocol
  • Patients receiving any investigational therapy within one month of signing the informed consent form
  • 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
  • Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telmisartan
4 weeks placebo run-in, 6-weeks fixed dose period
Drug: Placebo
Drug: Telmisartan
Active Comparator: Losartan + Hydrochlorothiazide
4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)
Drug: Placebo
Drug: Losartan + Hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM
Time Frame: Baseline (Day 28 of run-in period) and day 42
Baseline (Day 28 of run-in period) and day 42

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in 24-hour mean systolic blood pressure measured by ABPM
Time Frame: Baseline (Day 28 of run-in period) and day 42
Baseline (Day 28 of run-in period) and day 42
Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile
Time Frame: Baseline (Day 28 of run-in period) and day 42
Baseline (Day 28 of run-in period) and day 42
Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer
Time Frame: Baseline (Day 28 of run-in period) and day 42
Baseline (Day 28 of run-in period) and day 42
Number of patient with of adverse events
Time Frame: up to 10 weeks
up to 10 weeks
Changes from baseline in pulse rate
Time Frame: Baseline (Day 28 of run-in period) and day 42
Baseline (Day 28 of run-in period) and day 42
Changes in physical examination
Time Frame: Screening and day 43
Screening and day 43
Changes in laboratory parameters
Time Frame: Screening and day 43
Screening and day 43
Changes in 12-lead electrocardiogram (ECG)
Time Frame: Baseline (Day 29 of run-in period) and day 43
Baseline (Day 29 of run-in period) and day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 1998

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 1998

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 502.257

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