Telmisartan Versus Amlodipine in Patients With Mild-to-Moderate Hypertension

NCT02177409 | Completed Phase 3

• 1 other identifier: 502.258
• Study Type: interventional
• Target: 431
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of the trial is the effect of telmisartan versus amlodipine in lowering ambulatory diastolic and/or systolic blood pressures in the last six hours of the dosing interval in patients with mild-to-moderate hypertension as measured by ambulatory blood pressure monitoring (ABPM)

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  Baseline (day 1), day 57 of the open-label period

Secondary Outcomes (4)

• Changes from baseline in diastolic and systolic blood pressure during other times during the 24-hour ABPM profile

  Baseline (day 1), up to day 57 of the open-label period

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

  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 and 57 of the open-label period

• Blood pressure responder rates based on manual cuff measurements

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

Study Arms (2)

Telmisartan

EXPERIMENTAL

4-week placebo run-in, 8-week fixed dose period

Drug: Telmisartan; Drug: Placebo

Amlodipine

ACTIVE COMPARATOR

4-week placebo run-in, 8-week fixed dose period

Device: Amlodipine; Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Amlodipine DEVICE

Amlodipine

Placebo DRUG

Amlodipine; Telmisartan

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 a mean seated diastolic blood pressure (BP) 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
• Any women:
• 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 (CHF) (NYHA (New York Heart Association) class CHF 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

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: 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: 2014-07