Safety Evaluation of Telmisartan Plus Hydrochlorothiazide in Patients With Mild-to-Moderate Hypertension

NCT02177487 | Completed Phase 3

• 1 other identifier: 502.321
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess the safety of six month of open-label, treatment with the fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 12.5 mg in a subset of patients with mild-to-moderate hypertension who completed the eight week randomized, double blind 502.261 study.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (6)

• Incidence of adverse events

  up to 6 months

• Changes from baseline in laboratory tests

  Baseline and month 6

• Changes from baseline in physical examination

  Baseline and month 6

• Changes from baseline in 12-lead ECG (electrocardiogram)

  Baseline and month 6

• Changes from baseline in seated blood pressure

  Baseline, month 1, 3 and 6

• Changes from baseline in pulse rate

  Baseline, month 1, 3 and 6

Study Arms (1)

Telmisartan + Hydrochlorothiazide

EXPERIMENTAL

Drug: Telmisartan/hydrochlorothiazide

Interventions

Telmisartan/hydrochlorothiazide DRUG

Telmisartan + 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:

• All patients who were randomized and completed all study visits of the preceding double-blind trial with the fixed dose combination (502.261) who meet the following criteria:
• Patients that are not controlled on telmisartan 80 mg monotherapy at the final visit (Visit 6) of the 502.261 study
• Patients who are able to provide written informed consent
• Patients who are able to enter the study immediately upon their completion of the preceding double-blind trial of the fixed dose combination (502.261)

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 intrauterine device (IUD), oral, implantable or injectable contraceptives
• Any women:
• who has a positive serum pregnancy test at screening (Visit 1) or baseline (Visit 4)
• who has a positive urine pregnancy test prior to taking the first dose of open-label medication (at Visit 2)
• 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, hydrochlorothiazide drug combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 1999
• Primary Completion: January 1, 2000
• Last Updated: July 8, 2014

Record last verified: 2014-07