Telmisartan Compared to Losartan + Hydrochlorothiazide in Patients With Mild-to-moderate Essential Hypertension

NCT02183701 | Completed Phase 3

• 1 other identifier: 502.257
• Study Type: interventional
• Target: 715
• Locations: 0 countries
• Sites: N/A

Brief Summary

The general aim and clinical objective of this trial is to determine the effect of telmisartan 80 mg compared to losartan 50 mg + HCTZ (Hydrochlorothiazide) 12.5 mg on reduction of blood pressure (BP) in patients with mild to moderate hypertension as assessed by 24 hour Ambulatory Blood Pressure Monitoring (ABPM) and trough sitting BP cuff measurements at the end of the treatment.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour mean diastolic blood pressure measured by ABPM

  Baseline (Day 28 of run-in period) and day 42

Secondary Outcomes (8)

• Change from baseline in 24-hour mean systolic blood pressure measured by ABPM

  Baseline (Day 28 of run-in period) and day 42

• Change from baseline in systolic and diastolic blood pressures during other time periods during the 24-hour ABPM profile

  Baseline (Day 28 of run-in period) and day 42

• Change from baseline (Visit 2) in trough systolic and diastolic blood pressures measured by cuff sphygmomanometer

  Baseline (Day 28 of run-in period) and day 42

• Number of patient with of adverse events

  up to 10 weeks

• Changes from baseline in pulse rate

  Baseline (Day 28 of run-in period) and day 42

Study Arms (2)

Telmisartan

EXPERIMENTAL

4 weeks placebo run-in, 6-weeks fixed dose period

Drug: Telmisartan; Drug: Placebo

Losartan + Hydrochlorothiazide

ACTIVE COMPARATOR

4 weeks placebo run-in, 6-weeks fixed dose period (Losartan 50 mg / HCTZ 12.5 mg)

Drug: Losartan + Hydrochlorothiazide; Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Losartan + Hydrochlorothiazide DRUG

Losartan + Hydrochlorothiazide

Placebo DRUG

Losartan + Hydrochlorothiazide; 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 essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmHg measured by manual cuff sphygmomanometer, on Visit 2 of the four-week placebo run-in period (baseline)
• Mean seated systolic blood pressure ≥ 140 mmHg, measured by manual cuff at baseline (Visit 2)
• A 24-hour mean diastolic blood pressure , measured by ABPM, of ≥ 85 mmHg evaluated at baseline (Visit 3)
• Age 18 or older
• Patient's written informed consent in accordance with GCP (Good Clinical Practice) and local legislation

You may not qualify if:

• Pre-menopausal women (last menstruation ≤ 1 year prior to date of consent):
• Who are not surgically sterile (hysterectomy, tubal ligation)
• Who are NOT practising acceptable means of birth control or who do NOT plan to continue using an acceptable method throughout the trial. Acceptable methods of birth control include IUD (intrauterine device), oral, implantable or injectable contraceptives
• Who have a positive urine pregnancy test
• Who are nursing
• Mean seated diastolic blood pressure (DBP) \> 114 mmHg or mean seated systolic BP \> 200 mmHg, by manual cuff
• Any known hepatic and/or renal dysfunction as defined by the following laboratory parameters:
• SGPT (serum glutamate pyruvate transaminase) (ALT) or SGOT (serum glutamate oxaloacetate transaminase) (AST) greater than two times the upper limit of normal
• Serum creatinine \> 1.8 mg/dl (or 159 µmol/l)
• Clinically relevant hypokalemia
• Known or suspected secondary hypertension
• Known 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 3 months; stable angina where a change in nitrate therapy (dose or frequency) during the run-in period was required
• Stroke within the past 6 months prior to start of run-in period

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; hydrochlorothiazide, losartan 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 1998
• Primary Completion: December 1, 1998
• Last Updated: July 8, 2014

Record last verified: 2014-07