MICARDIS® and Valsartan in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring

NCT02177396 | Completed Phase 3

• 1 other identifier: 502.256
• Study Type: interventional
• Target: 426
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of the trial was to compare the effect of telmisartan and valsartan in lowering ambulatory diastolic and/or systolic blood pressure in the last six hours of the dosing interval. Secondary variables included changes from baseline in diastolic and systolic blood pressures during other times during the 24-hour ABPM profile, changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff, and responder rates. Assessment of safety was also considered. Adverse events and use of concomitant therapies were monitored at each study visit. Blood pressure and heart rate were collected at each visit. Physical examination, electrocardiograms (ECG) and laboratory tests were completed during the trial as well.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in diastolic and systolic blood pressure during the last 6 hours of a 24-hour dosing interval measured by ambulatory blood pressure monitoring (ABPM)

  Day 1 and 56 of the open-label period

Secondary Outcomes (5)

• Changes from baseline in diastolic and systolic blood pressures during other times during 24-hr ABPM profile

  Day 1 and 56 of the open-label period

• Changes from baseline in seated trough diastolic and systolic blood pressures as measured by manual cuff sphygmomanometer

  Baseline (day 27 of the single-blind period), days 1, 14, 28, 56 and 57 of the open-label period

• Blood pressure responder rates based on ABPM

  day 56 of the open-label period

• Blood pressure responder rates based manual cuff measurements

  days 14, 28, 56 and 57 of the open-label period

• Number of patients with adverse events

  up to 57 days

Study Arms (2)

Telmisartan

EXPERIMENTAL

Drug: Telmisartan; Drug: Placebo

Valsartan

ACTIVE COMPARATOR

Drug: Valsartan; Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Valsartan DRUG

Valsartan

Placebo DRUG

Telmisartan; Valsartan

Eligibility Criteria

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

You may qualify if:

• Mild to moderate hypertension defined as mean seated diastolic blood pressure measurement of ≥ 95 mm Hg and ≤ 114 mm Hg, measured by manual cuff sphygmomanometer, on the last visit (Visit 6) of the four-week placebo run-in period (baseline BP)
• Mean seated systolic blood pressure ≥ 140 mm Hg and ≤ 200 mm Hg, measured by manual cuff at Visit 6 (baseline BP)
• A 24-hour mean ABPM measurement of ≥ 130/85 mm Hg evaluated at Visit 7 (baseline ABPM)
• Age 18 or older
• Ability to provide written informed consent

You may not qualify if:

• Pre-menopausal women (last menstruation ≤ 1 year prior to start of screening):
• Who are not surgically sterile (hysterectomy, tubal ligation)
• Who are NOT practicing acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the study. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives
• Any woman:
• Who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 7)
• Who is nursing
• Hepatic and/or renal dysfunction as defined by the following laboratory parameters
• SGPT (ALT) (serum glutamate pyruvate transaminase) or SGOT (AST) (serum glutamate oxaloacetate transaminase) greater than two times the upper limit of normal
• Serum creatinine \> 2.3 mg/dL
• At screening (Visit 1): clinically relevant sodium depletion, hyperkalemia, or hypokalemia
• Known or suspected secondary hypertension
• Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; post-renal transplant patients, presence of only one functioning kidney
• Congestive heart failure (NYHA (New York Heart Association) functional class CHF (congestive heart failure) III-IV
• Unstable angina within the past three months
• Stroke within the past six months

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Valsartan

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; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• 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: April 1, 1998
• Primary Completion: December 1, 1998
• Last Updated: July 8, 2014

Record last verified: 2014-06