Telmisartan With or Without Hydrochlorothiazide in Patients With Mild-to-moderate Hypertension

NCT02177435 | Completed Phase 3

• 1 other identifier: 502.261
• Study Type: interventional
• Target: 491
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80) alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated trough diastolic blood pressure (DBP) after eight weeks of treatment.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in seated diastolic blood pressure (DBP) at trough

  Baseline (day 0), day 28, day 56

Secondary Outcomes (10)

• Change from baseline in seated systolic blood pressure (SBP) at trough

  Baseline (day 0), day 28, day 56

• Change from baseline in standing DBP and SBP at trough

  Baseline (day 0), day 28, day 56

• Blood pressure control (seated DBP < 90 mmHg)

  16 weeks

• Systolic blood pressure response

  16 weeks

• Number of patients with abnormal findings in physical examination

  Baseline (screening), day 0 and day 56

Study Arms (2)

Telmisartan plus Hydrochlorothiazide

EXPERIMENTAL

Drug: Telmisartan/Hydrochlorothiazide; Drug: Placebo

Telmisartan

EXPERIMENTAL

Drug: Telmisartan; Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Telmisartan/Hydrochlorothiazide DRUG

Telmisartan plus Hydrochlorothiazide

Placebo DRUG

Telmisartan; Telmisartan plus Hydrochlorothiazide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of mild-to-moderate hypertension
• Patients who fail to respond adequately to telmisartan monotherapy
• Participants between 18 and 80 years of age
• Ability to provide written informed consent

You may not qualify if:

• Patients taking more than three anti-hypertensive medications at the screening visit
• 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 4)
• 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
• Clinically relevant sodium depletion, hyperkalemia, or hypokalemia at baseline
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; telmisartan, hydrochlorothiazide drug combination

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: September 1, 1999
• Last Updated: July 8, 2014

Record last verified: 2014-07