Low-dose Nifedipine-Valsartan Combination Compared to Up-titrated Valsartan Monotherapy in Essential Hypertension

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Adalat (Nifedipine, BAYA1040); Drug: Diovan (Valsartan)

• Registration Number: NCT00993109
• Lead Sponsor: Bayer

Brief Summary

This will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. In the proposed study, the investigators will compare low-dose combination therapy of Nifedipine GITS/OROS plus Valsartan with up-titrated monotherapy of Valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.The study consists of a screening visit, followed by randomization and administration of either Nifedipine GITS/OROS 30 mg in combination with Valsartan 80 mg or Valsartan 160 mg for 12 weeks of treatment.The primary efficacy parameters will be mean SBP and DBP on office BP monitoring at 12 weeks of treatment compared to baseline.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-09
• Study First Posted: 2009-10-12
• Study Start: 2010-02
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Men and women aged 18 - 75 years
• Essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. Patients on prior treatment with monotherapy diuretic, ACE-I or beta blocker or an ARB other than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled.
• Office systolic blood pressure (sitting) >140 mmHg (sitting for >/= 5 min., no cigarettes and/or coffee/tea for >/=30 min. before BP measurement).
• BMI <33 kg/m2

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Exclusion Criteria

• Participation in any clinical investigational drug study within the previous 12 weeks

• Concomitant treatments with:

  1. Any anti-hypertensive treatment other than Valsartan 80 mg
  2. Cytochrome P450-3A4 inhibitors or inducers
  3. Potassium-sparing diuretics

• Severe hypertension (DBP >/= 110 mm Hg and/or SBP >/= 180 mm Hg) and/or evidence of secondary forms of hypertension

• Any of the following cardiovascular diseases:

• History of cardiovascular shock

• Myocardial infarction or unstable angina within the previous 6 months

• Severe cardiac valve disease

• Past or present severe rhythm or conduction disorder.

• Cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (SAH) within the previous 12 months

• Type 1 or 2 diabetes mellitus

• Proteinuria

• Uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia

• Gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)

• Cholestasis or biliary obstruction

• Liver disease or aspartate aminotransferase (AST) / alanine aminotransferase (ALT) levels >3 x upper limits of normal (ULN)

• Renal failure, creatinine level >2.0 mg/dl

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Adalat (Nifedipine, BAYA1040)	-
Arm 2	Diovan (Valsartan)	-

Primary Outcome Measures

Name	Time	Method
Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring	Baseline and 12 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)	8 and 12 weeks of treatment
Control rate (</=140/90 of office BP)	8 and 12 weeks of treatment
Change in pulse pressure (difference between SBP and DBP)	12 weeks of treatment
Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria	Baseline and 12 weeks of treatment
Adverse Event reporting	At the start, every 4 weeks during treatment and at the end of treatment
Vitals signs	At the start, every 4 weeks during treatment and at the end of treatment
Laboratory tests	At the start and at the end of treatment