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Zemplar Capsules

Clinical Pharmacology
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Clinical Pharmacology

Zemplar Capsules

The incidences of hypercalcemia (defined as two consecutive serum calcium values >10.5 mg/dL), hyperphosphatemia and elevated Ca x P product in Zemplar Capsules treated patients was similar to placebo. There were no treatment related adverse events associated with hypercalcemia or hyperphosphatemia in the Zemplar Capsules group. No increases in urinary calcium or phosphorous were detected in Zemplar Capsules treated patients compared to placebo.

The pattern of change in the mean values for serum iPTH during the studies are shown in Figure 1.

Figure 1. Mean Values for Serum iPTH Over Time in the Three Double-
Blind, Placebo-Controlled, Phase 3, CKD Stage 3 and 4 Studies
Combined


The mean changes from baseline to final treatment visit in serum iPTH, calcium, phosphorus, calcium-phosphorus product (Ca´P), and bone-specific alkaline phosphatase are shown in Table 2.

Table 2. Mean Changes from Baseline to Final Treatment Visit in Serum iPTH, Bone Specific Alkaline Phosphatase, Calcium, Phosphorus, and Calcium x Phosphorus Product in Three Double-Blind, Placebo-Controlled, Phase 3, CKD Stage 3 and 4 Studies Combined

 
Zemplar Capsules
Placebo
iPTH (pg/mL) n = 104 n = 110
   Mean Baseline Value 266 279
   Mean Final Treatment Value
 162 315
   Mean Change from Baseline (SE)
 -104 (9.2) +35 (9.0)
Bone Specific Alkaline Phosphatase (mcg/L) n = 101 n = 107
   Mean Baseline 17.1 18.8
   Mean Final Treatment Value 9.2 17.4
   Mean Change from Baseline (SE) -7.9 (0.76) -1.4 (0.74)
Calcium (mg/dL) n = 104 n = 110
   Mean Baseline 9.3 9.4
   Mean Final Treatment Value 9.5 9.3
   Mean Change from Baseline (SE) +0.2 (0.04) -0.1 (0.04)
Phosphorus (mg/dL) n = 104 n = 110
   Mean Baseline 4.0 4.0
   Mean Final Treatment Value 4.3 4.3
   Mean Change from Baseline (SE) +0.3 (0.08) +0.3 (0.08)
Calcium x Phosphorus Product (mg2/dL2) n = 104 n = 110
   Mean Baseline 36.7 36.9
   Mean Final Treatment Value 40.7 39.7
   Mean Change from Baseline (SE) +4.0 (0.74) +2.9 0.72)
Brand Name: Zemplar Capsules
Generic Name: Paricalcitol

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