- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02176499
Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension
7. juli 2014 oppdatert av: Boehringer Ingelheim
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
26
Fase
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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:
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Telmisartan, low dose
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)
|
|
Eksperimentell: Telmisartan, high dose
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)
|
|
Placebo komparator: Placebo
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)
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cumulative urinary sodium loss
Tidsramme: 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
|
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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cumulative urine sodium loss
Tidsramme: 0-24 hours post-dose on days 8-13 and 0-4, 4-8, 8-24 hours post-dose on day 14
|
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
Tidsramme: 24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
|
24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22
|
Changes in plasma norepinephrine
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in renin activity
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in aldosterone
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in urine potassium
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in creatinine chloride
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in bicarbonate
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
Changes in uric acid
Tidsramme: Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22
|
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
Tidsramme: 0-24 hours post-dose on days from day 15 to 22
|
0-24 hours post-dose on days from day 15 to 22
|
Changes in seated clinic blood pressure
Tidsramme: Baseline and day 14
|
Baseline and day 14
|
Changes in 24 hour ambulatory Blood Pressure (ABPM) after the first dose of telmisartan
Tidsramme: Day 0
|
Day 0
|
Number of patients with adverse events
Tidsramme: up to 50 days
|
up to 50 days
|
Number of patients with abnormal findings in physical examination
Tidsramme: Baseline and day 22
|
Baseline and day 22
|
Number of patients with abnormal findings in 12-lead electrocardiogram (ECG)
Tidsramme: Baseline and day 22
|
Baseline and day 22
|
Number of patients with abnormal changes in laboratory parameters
Tidsramme: Baseline and day 22
|
Baseline and day 22
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 1999
Primær fullføring (Faktiske)
1. juli 1999
Datoer for studieregistrering
Først innsendt
26. juni 2014
Først innsendt som oppfylte QC-kriteriene
26. juni 2014
Først lagt ut (Anslag)
27. juni 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. juli 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2014
Sist bekreftet
1. juli 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 502.255
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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