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

• ClinicalTrials.gov Identifier: NCT02242318
• Recruitment Status: Completed
• First Posted: September 17, 2014
• Last Update Posted: September 17, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: September 16, 2014
• First Posted Date: September 17, 2014
• Last Update Posted Date: September 17, 2014
• Study Start Date: September 2001
• Actual Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2014)

• Change in 24 hour mean Diastolic blood pressure (DBP) after a missed dose [ Time Frame: Baseline, Day 41, Day 55 ]
  measured by ambulatory blood pressure monitoring (ABPM)
• Change in mean DBP during the last 6 hours of the 24 hour dosing interval [ Time Frame: up to 8 weeks ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 16, 2014)

• Change in 24-hour mean systolic blood pressure (SBP) after a missed dose [ Time Frame: Baseline, Day 41, Day 55 ]
• Change in mean SBP during the last 6 hours of the 24-hour dosing interval [ Time Frame: up to 8 weeks ]
• Change in pulse pressure (PP) [ Time Frame: up to 8 weeks ]
• Change in 24-hour mean DBP after an active dose of study medication [ Time Frame: up to 8 weeks ]
• Change in 24-hour mean SBP after an active dose of study medication [ Time Frame: up to 8 weeks ]
• Change in mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after a missed dose [ Time Frame: up to 8 weeks ]
• Change in the mean seated trough SBP/DBP/PP in- clinic manual cuff sphygmomanometer after an active dose of study medication [ Time Frame: up to 8 weeks ]
• Responder rate measured by ABPM after a missed dose of study medication [ Time Frame: Baseline, Day 41, Day 55 ]
  • ABPM DBP "control" (24-hour mean DBP < 80 mmHg),
  • ABPM DBP "response" (24-hour mean DBP < 80 mmHg and/or reduction from baseline ≥ 10 mmHg),
  • ABPM SBP "response" (24-hour mean SBP < 130 mmHg and/or reduction from baseline ≥ 10 mmHg)
• Responder rate measured by ABPM after an active dose of study medication [ Time Frame: up to 8 weeks ]
  • ABPM DBP "control" (24-hour mean DBP < 80 mmHg),
  • ABPM DBP "response" (24-hour mean DBP < 80 mmHg and/or reduction from baseline ≥ 10 mmHg),
  • ABPM SBP "response" (24-hour mean SBP < 130 mmHg and/or reduction from baseline ≥ 10 mmHg)
• Responder rate in- clinic manual trough cuff measurements after a missed dose of study medication [ Time Frame: Baseline, Day 41, Day 55 ]
  • DBP "control" (DBP < 90 mmHg),
  • DBP "response" (DBP < 90 mmHg and/or fall of ≥ 10 mmHg),
  • SBP "response" (SBP < 140 mmHg and/or fall of ≥ 10 mmHg),
  • BP "normal" (SBP < 130 mmHg and DBP < 85 mmHg),
  • BP "normal / high normal" (SBP < 140 mmHg and DBP < 90 mmHg).
• Responder rate in- clinic manual trough cuff measurements after an active dose of study medication [ Time Frame: up to 8 weeks ]
  • DBP "control" (DBP < 90 mmHg),
  • DBP "response" (DBP < 90 mmHg and/or fall of ≥ 10 mmHg),
  • SBP "response" (SBP < 140 mmHg and/or fall of ≥ 10 mmHg),
  • BP "normal" (SBP < 130 mmHg and DBP < 85 mmHg),
  • BP "normal / high normal" (SBP < 140 mmHg and DBP < 90 mmHg).
• Number of patients with adverse events [ Time Frame: up to 8 weeks ]
• Change in 24-hour Pulse Pressure (PP) after a missed dose [ Time Frame: Baseline, Day 41, Day 55 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: A Prospective, Randomised, Double-blind, Double-dummy Trial to Compare the Efficacy of Micardis® (Telmisartan) (80 mg p.o. Once Daily) and Valsartan (160 mg p.o. Once Daily) in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring
• 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)
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: Telmisartan
• Drug: Valsartan
• Drug: Placebo

Study Arms

• Experimental: Telmisartan
  low dose for two weeks, then up titration to high dose, once daily
  Interventions:

  • Drug: Telmisartan
  • Drug: Placebo
• Active Comparator: Valsartan
  low dose for two weeks, then up titration to high dose, once daily
  Interventions:

  • Drug: Valsartan
  • Drug: Placebo
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 16, 2014): 440
• Original Actual Enrollment: Same as current
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. 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
2. 24-hour mean DBP of ≥ 85 mmHg at Visit 3 as measured by ABPM
3. Age 18 years or older
4. Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
5. Patient's written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

1. Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who

   1. are not surgically sterile,
   2. are nursing,
   3. 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)
2. Known or suspected secondary hypertension
3. Mean sitting SBP ≥180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in period

4. Hepatic and/or renal dysfunction as defined by the following laboratory parameters:

   1. 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,
   2. Serum creatinine > 2.3 mg/dL (or > 203 μmol/l)
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
6. Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
7. Uncorrected volume depletion
8. Primary aldosteronism
9. Hereditary fructose intolerance
10. Biliary obstructive disorders
11. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists
12. History of drug or alcohol dependency within six months prior to start of run-in period
13. Concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
14. Any investigational therapy within one month of signing the informed consent form
15. Congestive heart failure (New York Heart Association (NYHA) functional class Congestive Heart Failure (CHF III-IV))
16. Unstable angina within the past three months prior to start of run-in period
17. Stroke within the past six months prior to start of run-in period
18. Myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
19. Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past three months prior to start of run-in period
20. Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
21. Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
22. Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C ≥ 10%
23. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 Ante Meridiem (AM)
24. Known hypersensitivity to any component of the formulations
25. Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
26. Inability to comply with the protocol

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02242318
• Other Study ID Numbers: 502.376
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Boehringer Ingelheim
• Verification Date: September 2014