HypertensionPhase 3NCT02176499
Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension
A Phase 3 study testing Telmisartan, low dose and Telmisartan, high dose in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate hypertensive patients on a controlled sodium diet as well as to explore the effects of telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine potassium, creatinin, chloride, bicarbonate and uric acid… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan, low dose and Telmisartan, high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Feb 1999to Jul 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild-to-moderate hypertension as defined by a morning mean diastolic blood pressure from ≥ 90 and ≤ 115 mmHg and a mean systolic blood pressure ≤ 200 mmHg after five minutes in the seated position at the end of three weeks of placebo run-in treatment
- Male or female patients between 18 and 65 years of age, inclusive. Patients 60 to 65 years of age must have a screening 24-hour urine creatinine clearance rate of ≥ 1 mL/sec
- Ability to provide written informed consent
Who cannot join
- Pre-menopausal women (last menstruation ≤ one year to start of screening)
- Post-menopausal women (last menstruation > one year from start of screening or have had a hysterectomy and oophorectomy)
- Who have < three months of stable estrogen replacement therapy at screening
- Who will be on progesterone therapy at any time during the trial
- Known or suspected secondary hypertension
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Show all 28Show fewer
- ALT (alanine aminotransferase) or AST (aspartate aminotransferase) greater than two times the upper limit of reference range
- Serum creatinine greater than 2.3 mg/dL
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
- NYHA (New York Heart Association) functional class CHF (chronic heart failure) III-IV
- Unstable angina, myocardial infarction or cardiac surgery within the preceding three months
- Stroke within the preceding six months
- PTCA (percutaneous transluminal coronary angioplasty) within the preceding three months
- History of angioedema
- Sustained ventricular tachycardia, atrial fibrillation, or other clinically relevant cardiac arrhythmias as determined by the clinical Investigator
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
- Administration of digoxin or other digitalis-type drugs
- Patients with insulin-dependent and non-insulin-dependent diabetes mellitus
- History of drug or alcohol dependency
- Use of antihypertensive agents such as diuretics, ACE inhibitors, angiotensin II antagonists, α-blockers, β-blockers, calcium channel antagonists, direct vasodilators at any time during the trial
- Administration of other non-antihypertensive medications known to affect blood pressure (e.g., oral corticosteroids, MAO (monoamine oxidase) inhibitors, nitrates) at any time during the trial
- Chronic administration of high doses of NSAIDS and aspirin (e.g., ibuprofen for rheumatoid arthritis and osteoarthritis in total daily dose in excess of 1600 mg, aspirin in excess of 2 Gm per day)
- Chronic use of salt substitutes containing potassium chloride; potassium supplements; extreme dietary restrictions
- Clinically significant sodium depletion as defined by a serum sodium level less than 130 mEq/L
- Clinically significant hyperkalemia as defined by a serum potassium level greater than 6.0 mEq/L. Clinically significant hypokalemia as defined by a serum potassium level less than 3.0 mEq/L
- Patients receiving any investigational therapy within one month of signing the informed consent form. Note that patients who have participated in previous telmisartan studies may participate in this study provided there has been at least one month between discontinuing the previous study and signing the consent for the present study
- Known hypersensitivity to any component of telmisartan
- Any other clinical condition which, in the opinion of the principal Investigator, would not allow safe completion of the protocol and safe administration of trial medication
About this study
Official title: Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension On a Controlled Sodium Diet (100 mmol/Day)
Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate hypertensive patients on a controlled sodium diet as well as to explore the effects of telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was assessed whether the natriuretic effect disappears after treatment when telmisartan is stopped. The effects of telmisartan on seated clinic blood pressure and the relationship between urine sodium loss and decrease in ambulatory blood pressure after the first dose were assessed descriptively. Assessment of safety was also considered.
- Conditions
- Hypertension
- Being tested
- Telmisartan, low dose, Telmisartan, high dose, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan, low doseDrug
Telmisartan, high doseDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan, low dose | Experimental | 3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment ,1 week placebo wash-out (controlled sodium diet) Receives: Drug: Telmisartan, low dose; Drug: Placebo |
| Telmisartan, high dose | Experimental | 3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet) Receives: Drug: Telmisartan, high dose; Drug: Placebo |
| Placebo | Placebo comparator | 3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative urinary sodium loss
Measured: 0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6
Secondary outcomes (16)
Cumulative urine sodium loss
Measured: 0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
Changes in body weight
Measured: 24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
Changes in plasma norepinephrine
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in renin activity
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in aldosterone
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in urine potassium
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in creatinine chloride
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in bicarbonate
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in uric acid
Measured: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Cumulative urinary sodium gain during wash-out period
Measured: 0-24 hours post-dose on days from day 15 to 22
Changes in seated clinic blood pressure
Measured: Baseline and day 14
Changes in 24 hour ambulatory Blood Pressure (ABPM) after the first dose of telmisartan
Measured: Day 0
Number of patients with adverse events
Measured: up to 50 days
Number of patients with abnormal findings in physical examination
Measured: Baseline and day 22
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Measured: Baseline and day 22
Number of patients with abnormal changes in laboratory parameters
Measured: Baseline and day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startFeb 1999
- Primary completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176499
- Sponsor's protocol ID
- 502.255
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension On a Controlled Sodium Diet (100 mmol/Day)
- ClinicalTrials.gov ID
- NCT02176499
- Acronym / sponsor ID
- 502.255
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1999
- Primary completion
- Jul 1999 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate hypertensive patients on a controlled sodium diet as well as to explore the effects of telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was assessed whether the natriuretic effect disappears after treatment when telmisartan is stopped. The effects of telmisartan on seated clinic blood pressure and the relationship between urine sodium loss and decrease in ambulatory blood pressure after the first dose were assessed descriptively. Assessment of safety was also considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telmisartan, low dose | Experimental | Drug: Telmisartan, low dose, Drug: Placebo3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment ,1 week placebo wash-out (controlled sodium diet) |
| Telmisartan, high dose | Experimental | Drug: Telmisartan, high dose, Drug: Placebo3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet) |
| Placebo | Placebo comparator | Drug: Placebo3 weeks placebo run-in (normal diet), 1 week placebo run-in (controlled sodium diet), 2 weeks double-blind treatment, 1 week placebo wash-out (controlled sodium diet) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild-to-moderate hypertension as defined by a morning mean diastolic blood pressure from ≥ 90 and ≤ 115 mmHg and a mean systolic blood pressure ≤ 200 mmHg after five minutes in the seated position at the end of three weeks of placebo run-in treatment
- Male or female patients between 18 and 65 years of age, inclusive. Patients 60 to 65 years of age must have a screening 24-hour urine creatinine clearance rate of ≥ 1 mL/sec
- Ability to provide written informed consent
Key exclusion criteria (28 listed)
- Pre-menopausal women (last menstruation ≤ one year to start of screening)
- Post-menopausal women (last menstruation > one year from start of screening or have had a hysterectomy and oophorectomy)
- Known or suspected secondary hypertension
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan, low dose | Drug | Telmisartan, low dose |
| Telmisartan, high dose | Drug | Telmisartan, high dose |
| Placebo | Drug | Placebo, Telmisartan, high dose, Telmisartan, low dose |
Primary outcome
Cumulative urinary sodium loss
Time frame: 0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6
16 secondary outcomes
Cumulative urine sodium loss
Time frame: 0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
Changes in body weight
Time frame: 24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
Changes in plasma norepinephrine
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in renin activity
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in aldosterone
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in urine potassium
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in creatinine chloride
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in bicarbonate
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Changes in uric acid
Time frame: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
Cumulative urinary sodium gain during wash-out period
Time frame: 0-24 hours post-dose on days from day 15 to 22
Changes in seated clinic blood pressure
Time frame: Baseline and day 14
Changes in 24 hour ambulatory Blood Pressure (ABPM) after the first dose of telmisartan
Time frame: Day 0
Number of patients with adverse events
Time frame: up to 50 days
Number of patients with abnormal findings in physical examination
Time frame: Baseline and day 22
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Time frame: Baseline and day 22
Number of patients with abnormal changes in laboratory parameters
Time frame: Baseline and day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telmisartan, low dose and Telmisartan, high dose in people with Hypertension, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative urinary sodium loss (time frame: 0-4, 4-8, 8-24 hours post-dose at baseline, day 0, day 7 and 0-24 hours post-dose on days 1-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.