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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Adalat (Nifedipine, BAYA1040) (Drug); Diovan (Valsartan) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

Official title: Randomized,Open-label,Parallel Design Comparator Study of Effect of Nifedipine GITS/OROS (Adalat) 30 mg in Combination With Valsartan (Diovan) 80 mg Compared to Valsartan (Diovan) 160 mg Monotherapy in Patients Whose Blood Pressure is Not Well Controlled by Valsartan 80 mg Alone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Mean Systolic BP and Diastolic BP on office Blood Pressure monitoring

Secondary outcome:

Response rate (>/=10mmHg decrease of office SBP and >/=5mmHg decrease of office DBP)

Control rate (Change in pulse pressure (difference between SBP and DBP)

Reduction in Urinary microalbumin excretion(UAE) in patients with microalbuminuria

Adverse Event reporting

Vitals signs

Laboratory tests

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

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

Locations and Contacts

Beijing 100029, China

Beijing 100037, China

Shanghai 200025, China

Jongno-gu, Korea, Republic of

Jung-gu, Korea, Republic of

Seoul 110-744, Korea, Republic of

Seoul 120-752, Korea, Republic of

Guangzhou, Guangdong 510080, China

Donggu,, Gwangju Gwang''yeogsi 501757, Korea, Republic of

Bucheon-si,, Gyeonggido, Korea, Republic of

Yangsan-si, Gyeongnam, Korea, Republic of

Shijiazhuang, Hebei 050051, China

Changsha, Hunan 410008, China

Changsha, Hunan 410013, China

Nanjing, Jiangsu 210008, China

Nanjing, Jiangsu 210029, China

Shenyang, Liaoning 110001, China

Additional Information

Click here and search for drug information provided by the FDA.

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Click here to find results for studies related to Bayer Healthcare products.

Starting date: February 2010
Last updated: June 4, 2014

Page last updated: August 23, 2015

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