Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring

NCT02242318 | Completed Phase 4

• 1 other identifier: 502.376
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of the trial is to compare telmisartan 80 mg to valsartan 160 mg in lowering diastolic blood pressure in patients who missed a dose of their medication, as measured by ABPM (change from baseline in mean DBP over 24 hours), and to compare telmisartan 80 mg to valsartan 160 mg in lowering DBP during the last six hours of the dosing interval at the end of a 6 to 8-week treatment period, as measured by ABPM (change from baseline)

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose

  measured by ambulatory blood pressure monitoring (ABPM)

  Baseline, Day 41, Day 55

• Change in mean DBP during the last 6 hours of the 24 hour dosing interval

  up to 8 weeks

Secondary Outcomes (13)

• Change in 24-hour mean systolic blood pressure (SBP) after a missed dose

  Baseline, Day 41, Day 55

• Change in mean SBP during the last 6 hours of the 24-hour dosing interval

  up to 8 weeks

• Change in pulse pressure (PP)

  up to 8 weeks

• Change in 24-hour mean DBP after an active dose of study medication

  up to 8 weeks

• Change in 24-hour mean SBP after an active dose of study medication

  up to 8 weeks

Study Arms (3)

Telmisartan

EXPERIMENTAL

low dose for two weeks, then up titration to high dose, once daily

Drug: Telmisartan; Drug: Placebo

Valsartan

ACTIVE COMPARATOR

low dose for two weeks, then up titration to high dose, once daily

Drug: Valsartan; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Telmisartan DRUG

Telmisartan

Valsartan DRUG

Valsartan

Placebo DRUG

Placebo; 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 a mean seated diastolic blood pressure of ≥ 95 mmHg and ≤ 109 mmHg, measured by manual cuff sphygmomanometer, at Visit 2
• hour mean DBP of ≥ 85 mmHg at Visit 3 as measured by ABPM
• Age 18 years or older
• Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
• Patient's written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

You may not qualify if:

• Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
• are not surgically sterile,
• are nursing,
• are of child-bearing potential and are NOT practising acceptable methods of birth control, or do NOT plan to continue practising an acceptable method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives and Intra Uterine Devices (IUD)
• Known or suspected secondary hypertension
• Mean sitting SBP ≥180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in period
• Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
• Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) or Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) \> than 2 times the upper limit of normal range,
• Serum creatinine \> 2.3 mg/dL (or \> 203 μmol/l)
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
• Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
• Uncorrected volume depletion
• Primary aldosteronism
• Hereditary fructose intolerance
• Biliary obstructive disorders

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2001
• Primary Completion: September 1, 2002
• Last Updated: September 17, 2014

Record last verified: 2014-09