Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension

NCT02176499 | Completed Phase 3

• 1 other identifier: 502.255
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Cumulative urinary sodium loss

  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

  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

  24 hours post-dose on days -28, -21 to -14, -7, -1, 0, 7, 14 and 22

• Changes in plasma norepinephrine

  Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22

• Changes in renin activity

  Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22

• Changes in aldosterone

  Baseline, on day 0 after the end of the 24 hour dosing interval, on days 7, 14 and 22

Study Arms (3)

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)

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)

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)

Drug: Placebo

Interventions

Telmisartan, low dose DRUG

Telmisartan, low dose

Telmisartan, high dose DRUG

Telmisartan, high dose

Placebo DRUG

Placebo; Telmisartan, high dose; Telmisartan, low dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 27, 2014
• Study Start: February 1, 1999
• Primary Completion: July 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07